Gardasil VAERS Reports

FDA Freedom of Information Distribution
Report run on: 11 MAY 2007 03:14
VAERS Line List Report

Vax Name: HPV (GARDASIL) All comb. w/AND
Page 1
Vaers Id: 259545-1 (S) Related reports: 259545-2 Age Gender Vaccine Date Onset Date F 11-Jul-2006 11-Jul-2006 14.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 0
Received Date 14-Jul-2006 Lot 0637F
Status Date 14-Jul-2006
State DC
Mfr Report Id Route Unknown
Last Edit Date 13-Nov-2006 Other Vaccine
Prev Doses 0
Site Right arm
Seriousness: MedDRA PT
ER VISIT, HOSPITALIZED, SERIOUS Dehydration, Fall, Headache, Hyperventilation, Injection site pain, Muscle spasms, Speech disorder, Syncope, Vision blurred, Vomiting
Symptom Text: Immediately after injection complained of severe pain at site. Fell off table and fainted for approximately 10 - 15 seconds. Hyperventilated and cried progressing Chvostek's sign in hands and feet. Rebreathing into a bag progressing to clearing of symptoms. Complained of headache, blurry vision; Vision test was normal. Vomiting x 1 in parking lot and speech was momentarily inarticulate. Sent to ER. At ER neuro exam was normal except for word recall "coffee instead of coughing" "Sired instead of tired." Continued complaint of headache. Vomited x 2. All symptoms spontaneously cleared approximately 6 hours after incident. Overnight hospitalization for observation. Neurological evaluation before discharge was normal. Diagnosis also included dehydration. No fluids were taken from 7/10/2006 PM until IV in ER. Anion gap noted on chemistries and concentration of urine obtained after several hours of hydration. Discharge diagnosis: Dehydration, Vasovagal syncope secondary to shot vs pain at injection site. 7/17/06 Medical records received from reporter/provider which included vax record, office note of 7/11 & neuro consult of 7/15 by MD who also saw her in the hospital on 7/11-12. Neuro report indicates the CT scan of head was WNL & that dx is syncope probably precipitated by pain of vax injection along w/dehydration (no fluid intake since evening of 7/10 until IVF given in ER). As of 7/15 patient continued to have throbbing HA when bending down & also c/o strong heart beats ocassionally. PMH: dehydration requiring hospitalization at age 3 yo. Also has hx of mild anxiety. Family hx: patient's mother has Fuch's disease (genetic degenertive corneal disease which her mother also had) & patient's father has depression. There are no siblings. It was noted that she had 3 episodes of emesis following vax along w/ sustaining mild concussion when fell from exam table which was characterized by brief episode of aphasia, slurred speech & possible right facial paresis noted only by patient's mother./ss 10/27/06 Received medic NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: LABS: WBC 11.7, neutros 84, lymphs 9.7. Allergic rhinitis, spring pollens/ragweed/dust/mold


Page 2
Vaers Id: 259545-2 Age Gender F 14.0 VAX Detail: Type HPV4
Related reports: 259545-1 Vaccine Date Onset Date 11-Jul-2006 11-Jul-2006 Manufacturer MERCK & CO. INC.
Days 0
Received Date 16-Mar-2007 Lot NULL
Status Date 21-Mar-2007
State --
Mfr Report Id WAES0702USA03647 Route Unknown
Last Edit Date 22-Mar-2007 Other Vaccine
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Amblyopia, Fall, Headache, Pain, Speech disorder, Syncope, Syncope, Vomiting
Symptom Text: Information has been received via a company representative regarding an article as reported concerning a 14 year old female. On 11-JUL-2006, the patient was vaccinated with Gardasil (yeast). Immediately following the vaccination, the patient developed severe pain, fell off the examining table and experienced a 10 to 15 second fainting spell. It was reported that the patient ended up at the emergency room with a headache and speech problems. It was further that the patient had developed a syncopal episode combined with amblyopia (poor vision in one eye), abnormal speech and vomiting. At the time of this report, the outcome of the events were unknown. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 3
Vaers Id: 260144-1 Age Gender F 13.0 VAX Detail: Type HPV4 HEPA
Vaccine Date 25-Jul-2006
Onset Date 25-Jul-2006
Days 0
Received Date 26-Jul-2006 Lot 0637F 0144F
Status Date 28-Jul-2006
State CA
Mfr Report Id Route Unknown Unknown
Last Edit Date 10-Aug-2006 Other Vaccine
Manufacturer MERCK & CO. INC. MERCK & CO. INC.
Prev Doses 0
Site Left arm Right arm
NO CONDITIONS, NOT SERIOUS Dyskinesia, Hypertonia, Hypoaesthesia, Hypotonia, Pain, Syncope
Symptom Text: Patient received Hep A in right arm. Then received HPV in left arm. C/O pains, numbness. Started walking down hall fainted and had tonic/clonic movement for 15 sec. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BP 90/30 90/62 110/70 110/60, BG 114 Pulse OX 99, Strep culture neg. NONE Viral with low grade fever


Page 4
Related reports: 260907-2 Vaccine Date Onset Date 18-Jul-2006 18-Jul-2006 Manufacturer MERCK & CO. INC.
Days 0
Received Date 01-Aug-2006 Lot 0702F
Status Date 02-Aug-2006
State TX
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Rash, Swelling
Symptom Text: Swelling immediately after vaccine was administered, also rash. Ice pack was applied for 5 minutes and swelling decreases. Rash was still visible, but cream was applied. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE human papilloma virus, genital warts


Page 5
Related reports: 260907-1 Vaccine Date Onset Date Unknown Unknown Manufacturer MERCK & CO. INC.
Days
Received Date 15-Aug-2006 Lot NULL
State TX
Last Edit Date 19-Dec-2006 Other Vaccine
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pain, Swelling
Symptom Text: Information has been received from a physician concerning a 17 year old female who on unspecified date was vaccinated with a 0.5 ml of HPV rLI 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced painful swelling " the size of a golf ball". The patient recovered by the "next day". Unspecified medical attention was sought. Additional information has been requested. Unknown Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 6
Vaers Id: 261359-1 Age Gender F 11.0 VAX Detail: Type TD HPV4 MEN Seriousness: MedDRA PT
Onset Date Unknown
Days
Received Date 10-Aug-2006 Lot C2457AA 0702F U1920AA
State CA
Mfr Report Id Route Unknown Unknown Unknown
Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC. UNKNOWN MANUFACTURER
Prev Doses 5 0 0
Site Right arm Left arm Left arm
NO CONDITIONS, NOT SERIOUS Dizziness, Lymphadenopathy, Nausea
Symptom Text: Dizzy, nauseated, developed axillary lymphadenopathy on side with Menactra inoculation. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 7
Vaers Id: 261575-1 Age Gender F 24.0 VAX Detail: Type TDAP HPV4
Days 0
Received Date 15-Aug-2006 Lot NULL NULL
State CA
Mfr Report Id WAES0607USA041063 Route Unknown Unknown
Last Edit Date 25-Apr-2007 Other Vaccine
Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC.
Prev Doses
Site Unknown Unknown
ER VISIT, NOT SERIOUS Rash
Symptom Text: Information has been received from a physician concerning a 24 year old female with no medical history and no drug allergies who "last week" on approximately 12-JUL-2006 was vaccinated with HPV vaccine rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Concomitant therapy that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The vaccines were administered in different arms. Subsequently, "12 hours after vaccination" the patient developed a rash throughout her whole body that lasted for two days. Unspecified medical attention was sought. The patient recovered two days after injection. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 8
Days 0
State TX
Manufacturer MERCK & CO. INC.
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Pain, Swelling
Symptom Text: Information has been received from a physician concerning an approximately 16 year old female who on 19-JUL-2006 was vaccinated with HPV rLI 6 11 16 18 VLP vaccine (yeast). It was reported that "immediately after the injection", on 19-JUL-2006, the patient experienced pain and stinging at the injection site that lasted about 2 minutes and radiated the arm. The patient also reported feeling faint following the injection and experienced swelling. It was reported that the swelling went down but the pain persisted. Unspecified medical attention was sought. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 9
Days 0
State FL
Mfr Report Id WAES0607USA05727 Route Intramuscular
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Syncope
Symptom Text: Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27JUL-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 and a half to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no postictal state. Unspecified medical attention was sought. Subsequently, the same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 10
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain
Symptom Text: Information has been received from a physician and registered nurse concerning a 21 year old female with no medical history of drug allergies who on 27-JUL2006 was vaccinated intramuscularly in the left deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). Concomitant therapy included possible hormonal contraceptives (unspecified). On 27-JUL-2006 the patient experienced extreme pain at the injection site. The onset of the pain was immediate and lasted for 5 to 6 minutes and then resolved. Unspecified medical attention was sought. It was reported that the patient does not wish to continue the series of vaccinations. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 11
Vaers Id: 261579-1 Age Gender F 14.0 VAX Detail: Type HPV4 DTP
Days 0
Received Date 15-Aug-2006 Lot NULL NULL
State TX
Manufacturer MERCK & CO. INC. UNKNOWN MANUFACTURER
Prev Doses
Symptom Text: Information has been received from a physician concerning a 14 year old female who on 28-JUL-2006 was vaccinated with HPV rLI 3 11 16 18 VLP vaccine (yeast). Concomitant vaccination on 28-JUL-2006 included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. The patient stated that following vaccination on 28-JUL-2006, she " experienced a great deal of pain at the injection site". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 12
Related reports: 262070-2 Vaccine Date Onset Date 14-Aug-2006 22-Aug-2006 Manufacturer MERCK & CO. INC.
Days 8
State TX
Mfr Report Id Route Intramuscular
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Pruritus, Rash
Symptom Text: Patient developed a fine, red rash over torso and legs with itching reported on8/22/2006. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none OrthoTricyclen-Lo


Page 13
Days 5
Received Date 19-Sep-2006 Lot 0637F
Status Date 21-Sep-2006
State TX
Last Edit Date 05-Oct-2006 Other Vaccine
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pyrexia, Rash
Symptom Text: Information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history or drug allergies, who on 8/14/06 was vaccinated IM in the right deltoid with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (lot 653937/0637F). There was no concomitant medication. On 8/19/06 the pt notified her physicians office stating that she had developed a rash on both legs and torso. The pt did not experienced a fever . Unspecified medical attention was sought. Treatment advised was an antihistamine. Subsequently, the pt recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 14
Vaccine Date 14-Aug-2006
Onset Date 14-Aug-2006
Days 0
Received Date 25-Aug-2006 Lot 0637C
State NY
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Asthenia, Chills, Cyanosis, Dizziness, Pallor, Pyrexia, Visual disturbance
Symptom Text: 1 hr after vaccination, pt reported to feel dizzy, weak, vision went black for a few seconds, got pale with purple lips x 1/2hr. Felt better after drinking OJ. Then got temp 101F and chills x 1 day. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 15
Days 0
Received Date 29-Aug-2006 Lot 0637F 0706R
Status Date 31-Aug-2006 Site Left arm Left arm
State WA
Mfr Report Id Route Intramuscular Intramuscular
Prev Doses 0 1
ER VISIT, NOT SERIOUS Fall, Fracture, Syncope vasovagal
Symptom Text: Vasovagal syncope shortly after receiving hep A and Gardasil vaccine, fell, hit nose on a drawer, loss of consciousness, sent to ER in transport broke nose. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 16
Days 0
State WA
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Injury, Syncope, Tremor
Symptom Text: Vaccine given after physical. Pt fainted, vasovagal, hit head on carpeted cement floor. Loss of consciousness 1 min, had tonic posturing of right hand only some shaking. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: MRI next AM nl NONE NONE


Page 17
Days 1
State CA
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Rash, Urticaria
Symptom Text: Information has been received from a physician and a medical assistant concerning an 18 yr old female with no pertinent medical history or allergies, who on 17Aug06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5ml) (lot 653650/0702F). There was no concomitant therapy. Subsequently, on 18Aug06 the pt developed a rash and hives. It was reported that this was not an injection site rash. The pt presented to her physician's office on 18Aug06 with hives all over her body. She was treated with oral diphenhydramine hydrochloride (Benadryl). It was also reported that the pt went to the ER twice on 19Aug06 and 20Aug06 and was treated with intravenous methylprednisolone sodium succinate (Solu Medrol) for the hives and welts all over her body and was released (it was also reported that the pt was given IV saline). The pt was scheduled to have a follow up visit with her physician within a week. At the time of this report, the pt had not recovered. The rash and generalized urticaria were felt to be other important medical events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 18
Days 1
Status Date 01-Sep-2006 Site Left arm
State RI
Last Edit Date 01-Sep-2006 Other Vaccine
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Fatigue, Feeling hot, Injection site hypersensitivity, Injection site mass, Injection site pain
Symptom Text: Hard painful lump at site of injection, red, site is hot to the touch. Pt states feeling "tired & run down" since injection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 19
Vaers Id: 262735-1 (S) Related reports: 262735-2; 262735-3 Age Gender Vaccine Date Onset Date Days F 31-Jul-2006 13-Aug-2006 13 17.0 VAX Detail: Type MNQ HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Received Date 07-Sep-2006 Lot 42107AA 0697F
State MS
Prev Doses 0 0
Site Gluteous maxima Gluteous maxima
HOSPITALIZED, LIFE THREATENING, SERIOUS Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Proteinuria, Red blood cell sedimentation rate increased
Symptom Text: Vaccine was given on July 31 2006. She began having numbness and tingling in her feet and hands on or around August 13th or 14th, which persisted and slightly worsened until she was seen in our office on August 21st. Her neurological examination was normal, she had an elevated sedimation rate (39), mild protienuria, otherwize normal labs. MRI of her lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. She was referred to a neurologist and was seen on August 25th and was found to have weakened severely and was admitted to PICU for suspected Guillian-Barre syndrome which was confirmed by lumbar puncture. She was treated with IVIG with rapid improvement and has gone home. She is slowly improving and has residual weakness. Medical records including neurology received/reviewed. Final diagnosis is GBS. Was treated with IVIG as indicated on VAERS form. Per records pt has residual weakness. 12/19/06-progress notes received for and DC Summary DC DX: GBS. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: MRI of brain, cervical, thoracic and lumbosacral spine, drug screen, pregnancy test, sed rate, Blood count, blood chemistries, Lumbar Puncture.


Page 20
Received Date 15-Dec-2006 Lot 42107A 0697F
Status Date 29-Dec-2006
State MS
Mfr Report Id 200602493 Route Intramuscular Intramuscular
Prev Doses
HOSPITALIZED, SERIOUS Asthenia, Guillain-Barre syndrome, Hypoaesthesia
Symptom Text: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention (CDC). A 16 year old female patient had received an intramuscular, first dose injection of Menactra, lot number reported as 42017AA; and an intramuscular, first dose injection of Human Papillomavirus Recombinant Vaccine, lot number 0697F; on 31/Jul/2006. On or around 13/Aug/2006, the patient experienced numbness and tingling in her feet and hands. The symptoms persisted and had slightly worsened at the time of her examination by a physician on 21/Aug/2006. At that time, "neurological examination was normal." She had and elevated sedimentation rate (39), mild proteinuria, and "otherwise normal labs." Other laboratory tests performed, (specific results not provided), included a blood count, blood chemistries, pregnancy test and drug screen. MRI was performed of the brain, cervical, thoracic and lumbosacral spine. MRI of the lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. The patient was referred to and examined by a neurologist on 25/Aug/2006. During that exam, she was found to have weakened severely. She was admitted to a pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed by lumbar puncture. Lumbar puncture results were not provided. She was treated with IVIG with rapid improvement; and after five days of hospitalization, was discharged to home. Per the reported, she is slowly improving and had residual weakness. Recovery status was documented as unknown. As per the CDC this case was confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra vaccination. Follow-up information received 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the reported, the patient was hospitalized on 25/Aug/2006. The date of discharge was not reported. The patient's Guillain Barre Syndrome was confirmed by lumbar puncture testing. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 21
Received Date 08-Mar-2007 Lot 42107A 0697F
State MS
Prev Doses 0 0
Site Gluteous maxima Gluteous maxima
HOSPITALIZED, LIFE THREATENING, SERIOUS Areflexia, Asthenia, Asthenia, Cyst, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia, Laboratory test normal, Lumbar puncture, Muscular weakness, Nerve conduction studies abnormal, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Occupational therapy, Paraesthesia, Physiotherapy, Pregnancy test, Proteinuria, Red blood cell sedimentation rate increased
Symptom Text: Initial report received on 22/Sep/2006. A 16-year-old female patient had received an intramuscular, first dose injection of Menactra, lot number reported as 42107AA (not a valid manufacturer lot number), and intramuscular, first dose injection of Gardasil, lot number 0697F, on 31/Jul/2006. On or around 13/Aug/2006 or 14/Aug/2006, the patient experienced numbness and tingling in her feet and hands. The symptoms persisted and had slightly worsened at the time of her examination by a physician on 21/Aug/2006. At that time, neurological examination was normal. She had an elevated sedimentation rate (39), mild proteinuria, and otherwise normal labs. Other laboratory tests performed, (specific results not provided), included a blood count, blood chemistries, pregnancy test and drug screen. MRI was performed of the brain, cervical, thoracic and lumbosacral spine. MRI of the lumbosacral spine showed a (possibly old, chronic) subarachoid cyst. The patient was referred to and examined by a neurologist on 25/Aug/2006. During that exam, she was found to have weakened severely. She was admitted to a pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed by lumbar puncture. Lumbar puncture results were not provided. She was treated with IVIG with rapid improvement, and after five days of hospitalization, was discharged to home. Per the reporter, she is slowly improving and has residual weakness. Recovery status was documented as unknown. This case was confirmed as being Guillain Barre syndrome following Menactra vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, the patient was hospitalized on 25/Aug/2006. The date of discharge was not reported. The patient's Guillain Barre syndrome was confirmed by lumbar puncture testing. Literature citation, update: Guillain Barre syndrome among recipients of Menactra Meningococcal conjugate vaccine June 2005-September 2006. Follow-up information received on 19 October 2006 from a health care professional concerning a publication. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood chemistries normal, urinalysis Albuminuria, nerve conduction study GBS, MRI of LS spine, brain, Cervical, thoracic possibly old, Chronic subarachnoid cyst, blood drug screen normal, erythrocyte elevated, serum beta human normal, CBC n The patient was well on the day of immunization.


Page 22
Vaers Id: 262742-1 Age Gender F 15.0 VAX Detail: Type MNQ HPV4 HEPA Seriousness: MedDRA PT
Days 0
Received Date 08-Sep-2006 Lot NULL NULL NULL
State VA
Mfr Report Id WAES0608USA06904 Route Unknown Intramuscular Unknown
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. MERCK & CO. INC.
Prev Doses
Site Unknown Unknown Unknown
ER VISIT, OMIC, SERIOUS Convulsion, Injection site pain
Symptom Text: Information has been received from a physician concerning a 15 year old female patient who in August 2006, was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine. Prior to administration, the patient received the following concomitant therapy: hepatitis A vaccine and meningococcal ACYW conjugate vaccine. The patient had a mild seizure after receiving HPV rL1 6 11 16 18 VLP vaccine injection. She also complained of a great deal of pain at injection site. Medical attention was sought. It was reported that the patient recovered 1 day after the event. Her mother called the physician at home 1 day after the injections to state that the patient was fine. Upon internal review, mild seizure was considered to be an other important medical event (OMIC). Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 23
Days 1
Received Date 08-Sep-2006 Lot NULL
State --
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Chest discomfort, Erythema, Oedema peripheral
Symptom Text: Information has been received from a nurse concerning her 17 year old daughter with asthma who on 8/22/06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine (0.5ml). On 8/23/06 the patient developed a swollen thumb and her palms became red and hot. The patient later developed a tightness in her chest. The patient was immediately taken to a physician (an allergist who was the mother's employer) who immediately gave the patient a huge dose of cetirizine hydrochloride and acetaminophen as an intervention. The patient was not hospitalized and did not got to the emergency room. It was unknown if the affected site was the same arm that the vaccine was given in. The patient subsequently recovered from the red and hot palms, swollen thumb, and chest tightness on an unspecified date. The red and hot palms, swollen thumb and chest tightness were felt to be other important medical events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma


Page 24
Days 5
State TX
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Movement disorder
Symptom Text: 09/01/06 pt call with c/o decreased ROM in L arm 5 days after injection administration to current date. Tx with Naproxen x 10 days and Tylenol #3. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 25
Days 4
State GA
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Hypokinesia, Lymphadenopathy, Lymphadenopathy, Skin nodule
Symptom Text: Information had been received from a healthcare worker concerning a 17 year old female pt with a sulfonamide allergy who on 8/23/06 was vaccinated IM in left upper arm with a dose of HPV rL1 6 11 16 18 VLP vaccine yeast, lot 653736/089F. There was no concomitant medication. it was reported that 5 days after vaccination, on 8/27/06, the pt developed lymph node swelling in the clavicle area, described as grape size. The pt complained of interference of upper arm movement and felt something was present in the clavicle area. Unspecified blood work was done. On 8/29/06 a CAT scan was performed and lump was described as having 2 smaller and 1 larger lymph nodes involved. On 8/30/06 the pt was scheduled for surgery to have the lymph nodes removed and biopsied. As of the report date, the pt had not recovered. The reporter felt that the lymph node swelling and interference with upper arm movement were other important medical events (OMIC). Additional information has been requested. 10/13/06 Received medical records from hospital which reeal patient seen in ER 8/29/06 for enlarged lymph node left supraclavicular area which was tender to palpation. Final Dx: lymphadenopathy. 8/31/06 surgical biopsy done of left node & several other lymph nodes were palpated & sent to lab. NONE Other Meds: Computed axial 8/29/06 lump having 2 smaller and 1 larger lymph nodes involved. LABS: all WNL. CT of chest/abd/pelvis revealed 14mm circumscribed noe Lab Data: in left supraclavicular node & several less than 1 cm nodes in bilateral axillary areas Sulfonamide allergy History: Prex Illness: Prex Vax Illns:


Page 26
Vaers Id: 262809-2 (S) Related reports: 262809-1 Age Gender Vaccine Date Onset Date F 23-Aug-2006 27-Aug-2006 17.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 4
State GA
Prev Doses 0
ER VISIT, HOSPITALIZED, SERIOUS Lymphadenopathy
Symptom Text: Enlarged nodes in the clavicle area. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 27
Vaers Id: 262847-1 Age Gender F 25.0 VAX Detail: Type MNQ HPV4
Vaccine Date 06-Sep-2006
Onset Date 06-Sep-2006
Days 0
Received Date 11-Sep-2006 Lot U2117AA 0688F
State KY
Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses 0 0
Site Right arm Left arm
NO CONDITIONS, NOT SERIOUS Erythema, Joint range of motion decreased, Pain, Pain, Swelling
Symptom Text: Patient said right deltoid area, became red, swollen, quarter size hard knot, achy, painful to raise arm. Knot was hot to touch. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE yearly examination


Page 28
Related reports: 262872-2 Vaccine Date Onset Date 02-Sep-2006 02-Sep-2006 Manufacturer MERCK & CO. INC.
Days 0
Received Date 12-Sep-2006 Lot 08007
State FL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Syncope, Tonic clonic movements
Symptom Text: Immediately after vaccine administration patient had syncopal episode with tonic posturing fell from table. Responded with gentle stimulation versus normal 5 minutes post regaining full consciousness. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: vital signs stable NONE NONE


Page 29
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Fall
Symptom Text: Information has been received via a company representative regarding an article concerning a 11 year old female. On an unspecified date, the patient was vaccinated with Gardasil. Subsequently the patient fell from the examining table. At the time of this report, the outcome of the event was unknown. No further information is available. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 30
Vaers Id: 263024-1 Age Gender M 1.5 VAX Detail: Type PNC HPV4 DTAP Seriousness: MedDRA PT
Onset Date Unknown
Days
Received Date 13-Sep-2006 Lot B08682H NULL U1751AB
State NC
Mfr Report Id Route Intramuscular Unknown Intramuscular
Manufacturer LEDERLE LABORATORIES MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 2 3
Site Left leg Unknown Right leg
NO CONDITIONS, NOT SERIOUS Medication error
Symptom Text: Wrong vaccine was given Gardasil was given instead of Hep A by mistake. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 31
Vaers Id: 263032-1 (S) Related reports: 263032-2; 263032-3 Age Gender Vaccine Date Onset Date Days F 07-Jul-2006 20-Jul-2006 13 16.0 VAX Detail: Type MNQ HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Received Date 14-Sep-2006 Lot U2069AA 0637F
State IL
Prev Doses 0 0
HOSPITALIZED, SERIOUS Asthenia, Dehydration, Gait disturbance, Guillain-Barre syndrome, Paraesthesia, Psychomotor hyperactivity
Symptom Text: Guillain Barre. She was well on day of immunization but later said she was weak and several months this was not objectively noticed then, but shortly after the vaccine. 9/28/06 Received medical records from neurologists which reveal patient seen by PCP 7/31/06 with complaint of loss of strength over past 3 mos. Labs were done by PCP & showed mild dehydration & elevated neutrophils, eos were absent. Patient referred to neuro & initial eval on 8/3 reveals patient noted weakness beginning in June which had progressively worsened. Symptoms included tingling sensation at tip of fingers & significant weakness to the point she could not do her own hair. Birth history was WNL & only PMH is of ADD & has been on Adderall for about 1 year as well as BCP. Exam showed definite weakness of all extremities, esp upper extremities, & neck. Reflexes were absent in legs. Gait was normal but had difficulty taking steps w/o support & could not rise from sitting w/o help. Normal CPK made dx difficult & EMG/NCS was done on 8/4 which was strongly positive for GBS & copy of test included with records. Treated with IVIG x 2 days & placed in rehab facility on 8/5/06 for eval & therapy then received home PT. Seen by neuro next on 8/24 which showed improvement but still with weakness especially in the hands. Now able to rise from sitting on floor w/o support. Still no reflexes in legs. Complete but slow recovery was expected at that time/ss 9/28/06 Received medical records from hospital which reveal patient admitted 8/4/-8/6/06 for IVIG & PT./ss Adderall Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Attention deficit disorder.


Page 32
Received Date 15-Dec-2006 Lot U2069A 0637F
State IL
Prev Doses 0 0
HOSPITALIZED, SERIOUS Asthenia, Guillain-Barre syndrome
Symptom Text: Initial report received on 22/Sep/2006 from the Centers for Disease Control and Prevention. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA; and an intramuscular, first dose injection of Gardasil, lot number 06373F; on 07/Jul/2006. She had no illness at the time of vaccination. Concomitant medications included Adderall 50mg. Thirteen days post-vaccination, the patient experienced weakness "times several months." Although the report is difficult to read, it appears the reporter had written, "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. As per the CDC this case has not yet been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow up information, received on 27/Sep/2006 from the Centers for Disease Control and Prevention. Per the report, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms." Per the CDC comments regarding GBS confirmation status, "Unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post-vaccine Guillain Barre case." Adderall, oral contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: The patient had a history of attention deficit disorder for which she took Adderall 50mg.


Page 33
Received Date 21-Feb-2007 Lot U2069AA 0637F
Status Date 22-Feb-2007
State IL
Last Edit Date 22-Feb-2007 Other Vaccine
Prev Doses 0 0
HOSPITALIZED, SERIOUS Asthenia, Asthenia, Dehydration, Gait disturbance, Guillain-Barre syndrome, Hyperkinesia, Paraesthesia
Symptom Text: Initial report received on 22/Sep/2006. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA, and in intramuscular, first dose injection of Gardasil, Lot number 0637F, on 07/Jul/2006. She ha d no illness at the time of vaccination. Concomitant medications included Adderall 50 mg. Thirteen days post vaccination, the patient experienced weakness "times several months."Although the report is difficult to read, it appears the reporter had written, "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. This case has not yet been confirmed by CISA (Clinical immunization safety assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms. Comments regarding GBS confirmation status, "unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post vaccine Guillain Barre case. Follow up information received on 12 February 2007 from a manufacturer, whose reference number is WAES0702USA00828. This manufacturer received the original report. This manufacturer reported the lot number for Gardasil as being 653937/0637F. The lot number in the case was amended from 0637F to 653937/0637F per this ne Adderall, oral contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: The patient had a history of attention deficit disorder for which she took Adderall 50 mg.


Page 34
Days 0
State NY
Prev Doses 0
ER VISIT, NOT SERIOUS Dysphagia
Symptom Text: 2 hours after Gardasil Administration pt developed inability to swallow. Advised to take Benadryl by covering physician and go to ER. In ER not given EPI but Solumedrol to take for 5 days. Singulair, Allegra, Flovent, Rhinocort Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma, Penicillin allergy.


Page 35
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dysphagia
Symptom Text: Information has been received via a company representative regarding an article concerning a 15 year old female with asthma. On 29-AUG-2006, the patient was vaccinated with Gardasil. Concomitant therapy included four unspecified therapies for the treatment of asthma. On 29-AUG-2006, two hours post vaccination, the patient developed difficulty swallowing prompting a visit to the emergency room. At the time of this report, the outcome of the event was unknown. No further information is available. Therapy unspecified Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma UNK


Page 36
Vaers Id: 263200-1 Age Gender F Unknown VAX Detail: Type HPV4
Days 0
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pain
Symptom Text: Information has been received from a pharmacist concerning her daughter who on approximately 25-JUL-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). On approximately 25-JUL-2006 the patient experienced soreness at the injection site that lasted approximately one week and at the time of this report had not resolved. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 37
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Syncope
Symptom Text: Information has been received from a registered nurse concerning a female who on 02-AUG-2006 was vaccinated with the first dose of HPV rLi 3 11 16 18 VLP vaccine (yeast). It was reported that the patient fainted "shortly after receiving the vaccination". The nurse did not feel the experience was vaccine related and stated "the patient was very uneasy with the idea of an injection". The patient subsequently recovered "shortly after fainting". Unspecified medical attention was sought. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 38
Days 1
State CO
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pruritus, Rash, Rash papular, Skin burning sensation, Skin ulcer
Symptom Text: Information has been received from a registered nurse concerning a 14 year old female with seasonal allergies who was exposed to roseola on 25-JUL-2006 and had a fever on 02-AUG-2006. On 03-AUG-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Concomitant therapy included loratadine (CLARITIN) and vitamins (unspecified). On 04-AUG-2006, the patient developed an extensive rash. The patient discovered the rash at 7 am on the back of her legs. It was reported that the rash spread to her back and shoulders and had started to spread to her abdomen. The rash consisted of non vesicular papular single lesions that were slightly larger than a pinpoint and too numerous to count. The lesions were described as "burning and itchy". Unspecified medical attention was sought. At the time of the report, the patient's rash persisted. Additional information has been requested. CLARITIN, vitamins (unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE MEDICAL HISTORY: fever, CONCURRENT CONDITIONS: seasonal allergy


Page 39
Days 0
State TX
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Influenza like illness, Nausea, Pain, Pyrexia
Symptom Text: Information has been received form a physician concerning a 29 year old female with no pertinent medical history and no history of drug reactions allergies who on 8/9/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F) inappropriate schedule of vaccina administration. There was no concomitant medication. On 8/9/06 the pt experienced a fever, nausea, body aches, joint pains and experienced flu like symptoms. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the fever, nausea, body aches, joint pains and flu like symptoms. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 40
Days 0
State KY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Dysarthria, Injection site pain, Musculoskeletal stiffness, Pallor, Shock, Skin papilloma, Syncope
Symptom Text: Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4 minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past, on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards. The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described th Ortho Tri cyclen Lo Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood pressure 7/18/06 130/80 Pap smear abnormal, Dysplasia, Breast Prosthesis user.


Page 41
Days 3
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness
Symptom Text: Information has been received from a nurse concerning two female pts (WAES0609USA01112) who on approx 8/8/06 were vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot not provided). It was reported that after receiving the vaccinations both pts fainted. Additional information regarding the pts was not provided. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 42
Days 0
State TN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Myalgia, Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a physician concerning an 18 year old who on 14-AUG-2006 was vaccinated (yeast). Concomitant therapy included an unspecified therapy ("ESTRASTEP"). On 14-AUG-2006 the patient experienced profuse nausea, vomiting, low grade fever and myalgia. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. (therapy unspecified) Other Meds: body temperature 08/14/06 "low grade fever" Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 43
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Diarrhoea
Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female who on 08-AUG-2006 was vaccinated with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). Following the vaccination, on an unspecified date in August 2006, the patient experienced diarrhea. Unspecified medical attention was sought. At the time of this report, the outcome of the diarrhea was unknown. Additional information has been requested. ORTHO TRI CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 44
Vaers Id: 263208-1 Age Gender U Unknown VAX Detail: Type HPV4
Vaccine Date Unknown
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Urticaria
Symptom Text: Information has been received from a physician concerning a pt who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently the pt experienced hives. No further details were provided, and at the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 45
Days 0
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness
Symptom Text: Information has been received from a nurse concerning a 19 year old female with no pertinent medical history or drug reactions allergies who on 8/15/06 was vaccinated IM with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Menactra. On an unspecified date the pt was given tuberculin purified protein derivative. On 8/15/06, 5 minutes after vaccination with HPV rL1 6 11 16 18 VLP vaccine yeast, the pt became faint. The pt was given water and chocolate as treatment. Subsequently, the pt recovered on 8/15/06. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Tuberculin skin test NONE


Page 46
Days 0
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse concerning a 20 year old female with a penicillin allergy, drug hypersensitivity to cefaclor (CECLOR) and no other pertinent medical history reported. On 15-AUG-2006, the patient was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F). Concomitant therapy included paroxetine HCL (PAXIL), bupropion HCL (WELLBUTRIN) and famotidine. It was reported that the patient became faint within 5 minutes of vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast). The patient was given a soda to drink as treatment. There were no laboratory diagnostic studies performed. On 15-AUG-2006, the patient recovered from the event. Additional information has been requested. WELLBUTRIN, PEPCID, PAXIL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE CONCURRENT CONDITIONS: Penicillin allergy, drug hypersensitivity


Page 47
Days 1
State FL
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Pain
Symptom Text: Initial and follow up has been received from a healthcare worker in a physician's office concerning her 19 year old daughter who was a student and an unspecified person at the physician's office. On 11-AUG-2006, at 11:15 am, the patient was vaccinated intramuscularly in the deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F). Other concomitant therapy included an unspecified therapy ('LO-L"). On 12-AUG-2006 (previously reported as 14-AUG-2006) the patient developed pain in her right arm and ribcage on the same side where the vaccine was administered. On 16-AUG-2006, the patient had recovered from the events. No further information is available. (therapy unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 48
Days 0
State AR
Mfr Report Id WAES0608USA04253 Route Subcutaneously
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pruritus, Rash
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 14AUG-2006 was vaccinated subcutaneously with "the standard dose" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653736/0689F). There was no concomitant medication. ON 15-AUG-2006 the patient developed a rash on her face and experienced itching on her face. It was reported that the rash was only on the patient's face and not at the injection site or any other part of her body. The patient was instructed to take diphenhydramine hydrochloride (BENADRYL). On 17-AUG-2006, in the morning, the patient was instructed to take diphenhydramine hydrochloride (BENADRYL). On 17-AUG-2006, in the morning, the patient called her physician's office and reported that "it was responding to diphenhydramine hydrochloride (BENADRYL) but had not fully recovered". The patient was scheduled to be seen by her physician on 17-AUG-2006. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 49
Days 0
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 14 year old female with no pertinent medial history or drug reactions/allergies, who on 17-AUG2006 was vaccinated intramuscularly with HPV rLI 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). There was no concomitant medication. On 17-AUG2006, 15 minutes after receiving the vaccination, the patient "passed out" in the car on her way home. The patient was driven back to the physician's office, where she "woke up and was given soda and cold compresses". There was no reactions at the injection site and the patient had no additional reactions. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 50
Days 0
State MA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female who on 16-AUG-2006 was vaccinated intramuscularly in the deltoid with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml). The patient subsequently experienced severe injection site pain. It was reported that the patient remarked that the injection really hurt and that the pain flew down her arm. The patient rubbed her arm for a few minutes after receiving the injection. The patient subsequently went home and the nurse had not heard back from the patient. The patient was to be followed by her physician's office. The nurse also reported that she had not agitated the syringe prior to injection. At the time of this report, the outcome of the event was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 51
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Vomiting
Symptom Text: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies, who on 10-AUG2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). Concomitant therapy included ethinyl estradiol/norgestimate (TRINESSA). On 10-AUG-2006 the patient experienced multiple episodes of vomiting. Unspecified medical attention was sought. Subsequently, the patient recovered from the vomiting within 48 hours. Additional information has been requested. TRINESSA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 52
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Nausea
Symptom Text: Information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There was no concomitant medication. On 17aug-2006 the patient experienced nausea. Unspecified medical attention was sought. At the time of this report, the patient's nausea persisted. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 53
Days 0
State MA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning an 18 year old female with no known allergies and no other pertinent medical history reported. On 18AUG-2006, the patient was vaccinated intramuscularly in the deltoid with a 0.5 ml "single dose prefilled syringe" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F). There were no concomitant medication reported. On 18-AUG-2006, the patient developed severe injection site pain with HPV rLi 6 11 16 18 VLP vaccine (yeast) injection. The patient remarked that "it hurt and felt that the injection went to her head". The nurse reported that the patient felt faint immediately after the vaccination. The nurse had the patient lay down. It was reported that the patient "got up after 1 minute and said that she was ok.". The nurse reported that the "patient left the office immediately after this and the nurse was following up with the patient later today to make sure that the patient was ok." The nurse reported that she had not agitated the syringe prior to injection. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. On 18-AUG-2006, the patient recovered from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 54
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site reaction
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast). On an unspecified date, the patient developed "burning at the injection site". It was reported that the event improved after medical attention. It was reported that the event improved after "stopping therapy". At the time of this report, the outcome of the event was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 55
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Influenza like illness
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast). The day after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast), the patient developed "flu-like symptoms" (date unknown). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 56
Days 0
State IL
Prev Doses
Site Unknown
Symptom Text: Information has been received from a 22 year old female with an allergy to meperidine hydrochloride (DEMEROL) who on 21-AUG-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). On 21-AUG-2006, following the vaccination, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested. ORTHO TRI CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE CONCURRENT CONDITIONS: drug hypersensitivity


Page 57
Onset Date Unknown
Days
State AZ
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Injection site vesicles
Symptom Text: Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, she was vaccinated with her second dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, she developed a blister at the injection site. Medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 58
Onset Date Unknown
Days
State AZ
Prev Doses 1
Site Unknown


Page 59
Days 3
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Unevaluable event
Symptom Text: Information has been received from a nurse concerning two female patients who on approximately 08-AUG-2006 were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 60
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse concerning female college students 9exact number of patients unspecified) who were vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patients experienced injection site (deltoid) pain. At the time of this report, the outcome of the event was unknown. Further attempts are being made to identify the exact number of patients and identifiers of the patients involved in this report. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 61
Days 0
State TX
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Erythema, Erythema, Injection site pain, Pain
Symptom Text: Information has been receiving from a registered nurse concerning a 15 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Subsequently, on approximately 19-JUL-2006, the patient experienced burning at the injection site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry. The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema, and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (LOT#653937/0637F). Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 62
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Pyrexia
Symptom Text: Information has been received from a physician concerning a 24 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 63
Days 0
State MA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pain
Symptom Text: Information has been received from a 20 year old female patient who on 07-AUG-2006 was vaccinated intramuscularly with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The patient stated that "right after getting the shot" she experienced pain in the upper arm on and off throughout the day. She also stated that the pain"feels like she has a knife in her arm". Unspecified medical attention was sought. The patient was treated with Ibuprofen. As of the report date, she was recovering. Additional information has been requested. YAZ Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 64
Days 0
State RI
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Skin burning sensation
Symptom Text: Information has been received from a nurse practitioner concerning a 27 year old female who on 25-AUG-2006 was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast), lot#653650/0702F. During the administration of the vaccine, part of the fluid went into the patient's arm, the patient's arm, the patient pulled away and the remainder went on the skin (no adverse reaction noted). The patient complained of burning during administration. Medical attention was sought. The patient received a repeat dose with no burning noted. Patient's status was reported as recovered. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 65
Days 0
State TX
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Erythema, Erythema, Pain
Symptom Text: Information has been received from a registered nurse concerning a 17 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Subsequently on approximately site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry. The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema,and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown NONE


Page 66
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 19 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently,the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 67
Vaers Id: 263231-1 Age Gender M 18.0 VAX Detail: Type HPV4
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning an 18 year old male patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 68
Days 0
State NJ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Unevaluable event
Symptom Text: Information has been received from an other health professional concerning a 26 year old female in sales with no pre-existing allergies, birth defects or medical conditions reported. On 21-AUG-2006, in the pm, the patient was vaccinated in the left deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). There were no illness noted at the time of vaccination. On 21-AUG-2006, in the pm, the patient experienced an unspecified adverse event. The patient went to the emergency room and it was reported that she "went home that day". On 21-AUG-2006, the patient underwent a complete blood count (CBC), comprehensive metabolic panel, estimated glomerular filtration rate (GFR), urine microscopic analysis, urinalysis and an electrocardiogram (EKG). On 21-AUG-2006, the patient's laboratory data revealed an absolute neutrophil count noted as 7.9 K/ul, urine ketones noted as >-80, a urine white blood cell count noted as 30-40/hpf and urine bacteria noted as 4+. On 21-AUG-2006, the patient recovered from the events. Additional information has been requested. ORTHO TRI CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory 08/21/2006 "comprehensive metabolic panel tests", electrocardiogram 08/21/06, absolute neutrophil 08/21/06 7.9 K/ul 2.0-609, total urine ketones 08/21/06 >-80 negative, urine bacteria screen 08/21/2006 4+, urine WBC co NONE


Page 69
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a 26 year old female licensed practical nurse with no pertinent medical history and no known allergies or adverse drug reactions reported who on 07-AUG-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0696F). There were no concomitant medications reported. The licensed practical nurse reported that she received HPV rLi 6 11 16 18 VLP vaccine (yeast) in her deltoid from a pre-filled syringe. It was reported that when the injection was completed, the nurse administering it "let go of the plunger before taking it out of her arm" and the "spring shot the syringe out of the arm like a dart". It was reported that "some fluid leaked out of her arm". The licensed practical nurse reported that it "stung a little when the vaccine was administered" and then resolved in a few moments. The area of the spill was cleansed with alcohol. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. At the time of this report, the patient had recovered from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 70
Onset Date Unknown
Days
State WA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast). The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast)". The patient "fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient had not eaten anything. The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 71
Days 5
State NC
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash
Symptom Text: Information has been received from a physician concerning a 23 year old female who on approximately 24-AUG-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). On approximately 29-AUG-2006 (about 5 days after vaccination) the patient developed a rash (site of rash unspecified0. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 72
Onset Date Unknown
Days
State AZ
Prev Doses 1
Site Unknown


Page 73
Onset Date Unknown
Days
State RI
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site reaction
Symptom Text: Information has been received from a nurse practitioner concerning an unspecified number of patient's who were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) and complained of burning during administration. The patient's outcomes were not reported. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 74
Onset Date Unknown
Days
State WA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Syncope
Symptom Text: Information has been received from a physician concerning three patients (age and gender not reported) who on an unspecified date, in the morning, were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patients fainted after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast) (date unknown). It was reported that the patients had not eaten anything. At the time of this report, the outcome of the events were unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 75
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning 3 patients 9age and gender not reported) who on an unspecified date were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patients developed injection site pain (date unknown). The patients sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 76
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 26 year old female who on 30-AUG-2006 was vaccinated intramuscularly in her right arm with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ketorolac tromethamine (TORADOL). On 30-aUG-2006, the patient felt "dizzy" after the injection. The patient was then given a ketorolac tromethamine (TORADOL) injection and she "passed out" after receiving that injection (also reported as "dizziness followed by syncope"). It was reported that the patient was seeing the physician or her pain shot. The syncope occurred after her pain injection. The physician believed this was a vaso vagal response. It was reported that "it was not known if the patient was that she was scheduled to receive". The patient sought unspecified medical attention. It was reported that "she did not her second shot yet". On 30-AUG-2006, "a few minutes after", the patient recovered from the events. Additional information has been requested. TORADOL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 77
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Injection site swelling
Symptom Text: Information has been received from a physician concerning a female patient in her early 20's who was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced a high amount of pain and swelling at the injection site. Medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE Unknown


Page 78
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Pallor
Symptom Text: Information has been received from a physician concerning a 23 year old female. It was reported that it was "not known if the patient was pregnant, if she was taking any other medications or had a history of drug reactions or allergies." On an unspecified date, the patient was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient felt "light headed and dizzy" after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast). The patient also "turned very pale", but did not faint. At the time of this report, the outcome of the events were unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 79
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse in a physician's office concerning a female patient "in her 20's" who on an unspecified date was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient "fainted" after being given HPV rLi 6 11 16 18 VLP vaccine (yeast) (date unknown). At the time of this report, the outcome of the event was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 80
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse in a physician's office concerning a female patient "in her 20's" who on an unspecified date was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient "fainted" after being given HPV rLi 6 11 16 18 VLP vaccine (yeast) (date unknown). At the time of this report, the outcome of the event was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 81
Days 2
State ME
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Fungal infection, Pruritus
Symptom Text: About 2 days after administration of Gardasil pt reported onset of intense itching under armpit same side, has now been present for about 3 weeks, not improving. Possibly reaction to Gardasil vs fungal infection -avoid any irritants, no creams of soaps or deodorants -fungal cream twice a day -will report this as adverse event to Gardasil -reeval in 1 week Medications Added to Medication List This Visit: 1) Ketoconazole 2 % Crea (Ketoconazole) .... Apply twice a day Celexa 40mg 1 1/2 tabs po q day Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none known none known


Page 82
Days 1
Received Date 20-Sep-2006 Lot C2557AA 0637F
State CA
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Headache, Pyrexia, Rash
Symptom Text: On 8/29/06 pt woke up in am to rash on face and fever of 103. Rash not itchy. Treatment Tylenol or Motrin for fever. On 8/30/06 Pt continues with rash on face off and on and also fever continues. Temperature ranging 99.2 - . Also complains of headache. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Allergic rhinitis, RAD NONE


Page 83
Days 1
State WI
Last Edit Date 21-Sep-2006 Other Vaccine TDAP
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Arthralgia, Pain
Symptom Text: Right hypothenar eminence (thumb) started aching approximately 24 hours after shot administered, then the right wrist ached badly (i.e arthralgia). No other etiology of pain identified. Anaprox DS (Naproxen) and split provided. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 84
Days 0
State MA
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Convulsion, Syncope
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female with no other pertinent medical history, adverse drug reactions or allergies reported. On 9/6/06, at 3:30pm, the pt was vaccianted IM with the first dose of 0.5ml of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). Concomitant therapy included an unspecified hormonal contraceptives (also reported as birth control). On 9/6/06, the pt developed a mild seizure right after receiving HPV rL1 6 11 16 18 VLP vaccine yeast. The pt came to and immediately fainted again. The pt sought unspecified medical attention. It was reported that the pt had not eaten anything all day. After eating, the pt felt better. On 9/6/06, the pt had fully recovered from the events. Upon internal review, the mild seizure was considered to be an other important medical event. Additional information has been requested. Hormonal contraceptions. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 85
Days 1
State KS
Prev Doses 0
Site Gluteous maxima
NO CONDITIONS, NOT SERIOUS Breast disorder female, Tenderness
Symptom Text: Extreme Breast tenderness x 4 days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Ortho Tri cyclen LO x 6 years.


Page 86
Days 0
Status Date 05-Oct-2006
State CA
Prev Doses 1
Site Right arm
Symptom Text: Pt fainted. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seasonal NONE


Page 87
Days 7
Status Date 05-Oct-2006 Site Left arm
State NC
Last Edit Date 05-Oct-2006 Other Vaccine MNQ
Prev Doses 0
ER VISIT, NOT SERIOUS Blister, Erythema, Hypersensitivity, Rash erythematous
Symptom Text: Raised erythematous patchy rash of left shoulder (Behind left deltoid muscle) with slight vesicles. Also similar linear rash on left leg (appearance of delayed hypersensitivity) rash began 1 week after injection. Singular, Zyrtec Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Seasonal allergic rhinitis. NONE


Page 88
Days 7
State MO
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash pruritic
Symptom Text: Itchy bumps, 1 on arm, 1 on breast, 1 on back. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Birth Control Seasonal


Page 89
Onset Date Unknown
Days
State MO
Prev Doses 0
Site Unknown
Symptom Text: Itchy bumps 1 on back, 1 on arm, 1 on leg. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 90
Days 7
State TX
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Joint range of motion decreased, Pain
Symptom Text: One week post injection, complain of achy arm where injection was given, difficult to raise arm, no swelling or redness at injection site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Phentermine 37.5 mg as needed NONE NONE NONE


Page 91
Days 1
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site reaction, Rash
Symptom Text: Rash at injection site at 24 hours after administration, then rash on other arm (at corresponding site) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Yasmin NONE possible polycystic ovary syndrome NONE


Page 92
Days 0
State KY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site warmth, Pruritus, Urticaria
Symptom Text: Hives on neck and chest, injection site red, warm to touch, itching at area and on palms of hands. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BUSPAR, ATIVAN, CELEXA took two BENADRYL Penicillin NONE


Page 93
Days 1
Received Date 02-Oct-2006 Lot 0702F
State IL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Anorexia, Back pain, Fatigue, Headache, Pyrexia
Symptom Text: Fatigue, Headache, Backaches, Temp 103, no appetite, x 3 days then was ok no treatment. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 94
Vaccine Date 02-Oct-2006
Onset Date 02-Oct-2006
Days 0
Received Date 16-Nov-2006 Lot UNK
Status Date 22-Nov-2006
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a consumer concerning her 20 year old daughter who on 02-OCT-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The patient experienced dizziness for a short period of time after the vaccination. Medical attention was sought. It was reported that the patient has a fear of needles and that may have been a causal factor. No further information is available. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 95
Days 0
State ME
Prev Doses
ER VISIT, OMIC, SERIOUS Dyspnoea, Injection site swelling, Nasopharyngitis, Swelling face
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female with asthma, polycystic ovaries and no known allergies or adverse drug reactions reported. On 25-SEP-2006, the patient was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653735/0688F). Concomitant therapy included bupropion HCL (WELLBUTRIN XL), lithium carbonate and risperidone (RISPERDAL). That evening, on 25-SEP-2006, the patient developed left arm swelling and difficulty breathing. It was reported that the difficulty breathing could be due to the patient having a cold and being an asthmatic. On 26-SEP-2006 the patient developed facial swelling. The patient sought unspecified medical attention. It was reported that a nurse practitioner and physician were doing an assessment and consultation. At the time of this report, the patient was recovering from th events. The reporter considered the events to be serious as other important medical events. Additional information has been requested. (OMIC) Wellbutrin XL; lithium carbonate; Risperdal Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma; Polycystic ovaries; cold


Page 96
Days 0
State RI
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site warmth, Pain, Pyrexia
Symptom Text: FEVER, SITE WARM TO TOUCH, PAIN NOTED WITH MOVEMENT OF EXTREMITY. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 97
Vaers Id: 264066-1 Age Gender F 16.0 VAX Detail: Type TDAP HPV4 MNQ Seriousness: MedDRA PT
Days 0
Received Date 06-Oct-2006 Lot C2556AA 0637F U2108AA
State WI
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 0 0 0
Site Left arm Right arm Right arm
NO CONDITIONS, NOT SERIOUS Injection site induration, Injection site reaction, Injection site warmth
Symptom Text: 2 separate reactions Tdap 6x4 1/2" area hot to touch. Induration of biceps upper arm started day of injection given seen in office 9/28/06, Gardasil 3 1/2 x 3" hot to touch started 3 days after shot for both ice and Ibuprophen. Prozac, Abilify, Lamictal. Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: allergies, sinusitis, Bipolar disorder.


Page 98
Days 4
Received Date 09-Oct-2006 Lot C2559BA 0637F U2114AA
State CA
Mfr Report Id Route Intramuscular Intramuscular Intramuscular
Prev Doses 0 0 0
Site Left arm Right arm Left arm
ER VISIT, NOT SERIOUS Pruritus, Urticaria
Symptom Text: Urticaria (hives) developed 4 days after vaccines were given covered torso and extremities, extremely itchy. Pt was given Benadryl Zyrtec, Prednisone orally and took a bath with baking soda. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 99
Days 1
State MA
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Coma, Mental impairment, Urticaria
Symptom Text: 09/13/06 pt went to school where she developed hives at 10am. She was sent home, mom came home and found pt unresponsive and called 911. Pt seen at ER. Became responsive and talking well at ER. Exam WNL. DX'd changed mental status sent home. Lithium, Propanolol, Prozac, Seraguel, Clozapine, Ritalin, Aviane, Keflex. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: At ER 9/13/06 EKG sinus arrhythmia, chest X ray NL, CT head normal, CBC, U/A, Lytes and toxic screen neg NL. Bipolar DS, ADHS, left hydronephrosis. NONE


Page 100
Vaers Id: 264209-1 Age Gender F 12.0 VAX Detail: Type TDAP HPV4 IPV MMRV Seriousness: MedDRA PT
Days 0
Received Date 10-Oct-2006 Lot AC52B002AA B229AA Y1067 0816F
State --
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Intramuscular
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses 4 0 1 0
Site Left arm Right arm Left arm Right arm
NO CONDITIONS, NOT SERIOUS Cellulitis, Injection site reaction
Symptom Text: Cellulitis at injection site Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 101
Days 0
Received Date 11-Oct-2006 Lot NULL
State FR
Mfr Report Id WAES0610CAN00009 Route Unknown
Prev Doses
Site Unknown
OMIC, SERIOUS Anaphylactic reaction, Malaise
Symptom Text: Information has been received from a consumer concerning her 15 year old daughter with asthma, peanut allergy and allergy to nuts and a history of anaphylaxis (three episodes of anaphylaxis (first at age 8) related to allergy to peanuts/nuts) who on 9/29/06 was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine yeast at approx 16:00. Concomitant therapy included Ventolin (rarely uses it ). The pt stayed in the physicians office for about half an hour with the clinic staff ready for an allergic anaphylactic reaction since she had three episodes of anaphylaxis previously. However she felt fine. On 9/29/06 the pt experienced anaphylactic reaction described as going into shock at approx 20:00 she suddenly felt ill (anaphylactic reaction that could not be traced back to food eaten that day that could have contained nuts). The pt immediately administered on Epi Pen dose. Subsequently the pt was taken to the emergency dept where she received supportive care only as no other medications were needed. Subsequently, the pt recovered from anaphylactic reaction. Upon internal review anaphylactic reaction was considered other important medical event (OMIC). Additional information has been requested. VENTOLIN (ALBUTEROL) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Anaphylaxis peanut allergy, allergy to nuts Asthma.


Page 102
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Joint range of motion decreased
Symptom Text: Information has been received from a physician concerning a 19 year old female who in early August 2006, was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml). The physician reported that at the time of vaccination, the patient experienced injection site pain. The patient later experienced decreased range of motion in the arm she received the vaccination. It was reported that the patient's arm hurt when she raised it above her head. At the time of this report, the patient's injection site pain, decreased range of motion in arm pain persisted. Unspecified medical attention was sought. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Unknown


Page 103
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female who on 01 Sep 2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702P). The nurse reported that she was very unhappy with the syringe. The nurse reported that she "had received no instructions, and upon using the syringe for the first time, the safety device activated as soon as she pushed all the way down on the plunger, and it hit the patient in the arm". The nurse also reported that she had not read the product insert prior to administering the vaccine, as it was not available in the carton, and as soon as she administered the full dose of vaccine, she immediately let go of the plunger. She also reported that "it was loud, which scared the patient, and the needle coil sprang out and hurt the patient. The patient was kept in the office longer than normal since the coil hit the patient against her arm and hurt her. Unspecified medical attention was sought. The nurse was able to administer the entire dose of vaccine. On 05-Sep-2006 the patient had recovered. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 104
Days 0
State OR
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injury, Medication error
Symptom Text: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history or drug reaction/allergies, who on 8/31/06 was vaccinated IM with a pre filled syringe HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). There was no concomitant therapy. The medical assistant reported that the spring action activated so forceful the needle and spring popped out of the clients left arm and scratched her. It was reported that all the vaccine was administered and that the pts left arm was washed with soap and water. She also reported that the pt did not bleed. No further details were provided. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 105
Days 1
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Urticaria
Symptom Text: Information has been received from a registered nurse concerning a female pt (age not provided) who on approx 8/22/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot not provided). The nurse reported that a day and half after receiving the vaccine, on approx 8/23/06 the pt developed what appeared to be hives. Unspecified medical attention was sought. Subsequently, the p0t recovered from the hives. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 106
Onset Date Unknown
Days
State WI
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine yeast. It was reported that the pt fainted after the injection (date unk). The pt sought unspecified medical attention. AT the time of this report, the pt had recovered from the event (date unk). Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 107
Days 0
State TX
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning her 13 year old daughter who on approx 8/16/06, (also reported as within the past 2-3 weeks) was vaccinated with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast. the physician reported that her daughter experienced soreness at injection site for a couple of days after receiving HPV vaccine. The pt sought unspecified medical attention. At the time of this report, the outcome of the event was unk. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 108
Days 0
State MT
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dysgeusia, Hyperhidrosis, Nausea
Symptom Text: Information has been received from a licensed practical nurse concerning a 27 year old female with no pertinent medical history or drug reactions. allergies, who on 9/7/06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653736/0689F). Concomitant therapy included ethinyl Estradiol norgestimate (Ortho Tri Cyclen). On 9/7/06, immediately after receiving the vaccine, the pt experienced a metallic taste in her mouth, nausea and sweating. The nurse had the pt lay down for a little while and the pt started to feel better. No further details were provided. At the time of this report, the pt was recovering. Additional information has been requested. Ortho Tri Cyclen Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 109
Vaers Id: 264373-1 Age Gender F Unknown VAX Detail: Type HPV4 DTAP
Onset Date Unknown
Days
Received Date 11-Oct-2006 Lot NULL NULL
State CA
Mfr Report Id WAES0609USA01470 Route Intramuscular Unknown
Prev Doses
ER VISIT, NOT SERIOUS Pyrexia, Rash, Rash macular
Symptom Text: Information has been received from a physician concerning a female who on an unspecified date was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Dtap. The day after vaccination with HPV the pt developed a blotchy rash which lasted for three days (site of rash not specified). It was also reported that the pt experienced a fever with a temp between 99 and 103 degrees during the same three day period. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the rash and fever. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Body temp between 99 and 103 degrees. UNK


Page 110
Onset Date Unknown
Days
State WA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Hypoxia
Symptom Text: Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (date unknown). It was reported that the pt felt dizzy and was administered oxygen. The pt was observed for 30 minutes (previously reported that the pt had not eaten anything. At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 111
Onset Date Unknown
Days
State WA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Syncope
Symptom Text: Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently, the pt fainted after receiving HPV vaccine (date unk). It was reported that the pt felt dizzy and was kept for observation (previously reported that the pt had no eaten anything). At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 112
Days 3
State AZ
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Aphthous stomatitis, Herpes simplex, Malaise, Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Skin ulcer, Vomiting
Symptom Text: Information has been received from a physician concerning a 22 year old female with no pertinent medical history and no allergies, who on 8/30/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. On 9/2/06 the pt developed a canker sore on her lip and sore throat. On 9/6/06 she experienced nausea, vomiting, malaise, a temperature of 102F and developed a herpetic ulcerative ring on her left ring finger. It was also reported that the pt experienced myalgia. Unspecified medical attention was sought/ Subsequently, it was reported on 9/8/06 that the symptoms were subsiding, the lesion on the pts lip had crusted and her temp was 98.9F. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Body temp 9/6/06 102F, body temp 9/8/06 98.9F. NONE


Page 113
Days 1
State MO
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Skin discolouration, Sunburn
Symptom Text: Information has been received from a certified medical assistant concerning a 19 year old female with no pertinent medical history and no known allergies or adverse drug reactions reported. On 9/5/06, the pt was vaccinated IM with one dose of HPV rL1 6 11 16 18 VLP vaccine yeast. Concomitant therapy included Ortho Tri Cyclen. It was reported that the pt woke up the next morning and her skin was pink from head to toe. There was no rash, no pain, no itching, no swelling and no hives. It was reported that her only symptom was a sunburn like appearance to her skin. the pt sought unspecified medical attention. On 9/7/06 in the evening, the color began to subside. As of 9/8/06 her skin was reported as looks better and the pt was noted as recovering. Additional information has been requested. Ortho Tri Cyclen Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 114
Vaers Id: 264556-1 Age Gender F 16.0 VAX Detail: Type HPV4 HEP FLU Seriousness: MedDRA PT
Days 0
Received Date 16-Oct-2006 Lot 0955F 0223F U2239AA
State IN
Manufacturer MERCK & CO. INC. MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 0 1 1
Symptom Text: Pain in right upper arm from time of administration of vaccine and continuing 8 days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 115
Days 0
State KY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Hyperhidrosis, Nausea, Pallor, Peripheral coldness
Symptom Text: Pt experienced paleness, sweating, cold hands, nausea, dizziness and lightheadedness. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 116
Days 0
State TX
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Dyspnoea, Pyrexia
Symptom Text: Information has been received from a physician concerning an 18 year old female who on 14-SEP-2006 was vaccinated intramuscularly with a first 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). About an hour after receiving the vaccine, the patient developed shortness of breath and a fever. The patient was directed to the emergency room. It was noted that the patient's symptoms improved "on therapy" (unspecified). No product quality compliant was involved. Shortness of breath and fever were considered to be other important medical events. Additional information has been requested. (OMIC) UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 117
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
OMIC, SERIOUS Abdominal pain, Hepatitis
Symptom Text: Information has been received from a physician concerning a pt who was vaccinated with a dose of HPV vaccine yeast. Subsequently the pt experienced a recurrence of hepatitis and abdominal pain. The physicians office manager reported that the pt tested positive for hepatitis after receiving the vaccine. The pts outcome was not reported. Recurrence of hepatitis and abdominal pain were considered to be other important medical events (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 118
Vaers Id: 264684-1 (S) Related reports: 264684-2 Age Gender Vaccine Date Onset Date M 02-Oct-2006 04-Oct-2006 0.2 VAX Detail: Type ROTHB5 Manufacturer MERCK & CO. INC.
Days 2
State GA
Mfr Report Id WAES0610USA06268 Route By Mouth
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, OMIC, PERMANENT DISABILITY, SERIOUS Acidosis, Dehydration, Diarrhoea, Vomiting
Symptom Text: Information has been received from a registered nurse concerning a 9 week old male, with no medical history and no allergies, who on 02-OCT-2006 was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There was no concomitant medication. On 04-OCT2006 the patient developed vomiting. He was seen at the physician's office on 06-OCT-2006 and by then was experiencing vomiting and loose stools. He was admitted to the hospital on 09-OCT-2006 for vomiting, diarrhea, and acidotic dehydration. He was being given intravenous fluids. At the time of the report the patient had not recovered. Vomiting, diarrhea, and acidotic dehydration were considered to disabling, life threatening, and other important medical events by the reporter. Additional information has been requested. (OMIC) NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 119
Related reports: 264684-1 Vaers Id: 264684-2 (S) Age Gender Vaccine Date Onset Date M 02-Oct-2006 09-Oct-2006 0.2 VAX Detail: Type PNC IPV HPV4 DTAP HBHEPB Seriousness: MedDRA PT Manufacturer LEDERLE LABORATORIES AVENTIS PASTEUR MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC.
Days 7
Received Date 02-Jan-2007 Lot C086910 Z0240 0607F C2489AA 0269F
Status Date 03-Jan-2007 Site Right leg Left leg
State GA
Mfr Report Id 200603514 Route Unknown Unknown By Mouth Unknown Unknown
Last Edit Date 03-Jan-2007 Other Vaccine
Prev Doses 0 0 0 0 0
Unknown Left leg Right leg
ER VISIT, HOSPITALIZED, LIFE THREATENING, OMIC, PERMANENT DISABILITY, SERIOUS Acidosis, Bacterial infection, Blood urine, Chromaturia, Decreased appetite, Dehydration, Diarrhoea, Enteritis, Faeces discoloured, Gastroenteritis, Haematochezia, Intussusception, Malaise, Pyrexia, Viral infection, Vomiting
Symptom Text: Initial report received on 15 December 2006 from an other manufacturer, report number WAES0610USA06268, who received the original report from a health care professional. This report is a follow up report to previously submitted reports by the other manufacturer on 13 October 2006, 30 October 2006, and 11 December 2006. Information has been received by the other manufacturer, from a registered nurse concerning a 9 week old male, with no concurrent illnesses, no medical history, and no allergies, who on 02 October 2006, at 13:00pm, was vaccinated with a first dose , left leg (route not reported) administration of IPOL, lot number Z0240, a first dose, left leg (route not reported) administration of Tripedia, lot number C2489AA, a first dose, right leg 9route not reported0 administration of Comvax, lot number 654538/0269T, a first dose, right leg (route not reported) administration of Prevnar, lot number B086910, and a first 2.0ml oral dose of Rotateq, lot number 654422/0607F. Reportedly, there were no adverse events following prior vaccinations. On 04 October 2006, the patient vomited one time and decreased appetite. He again vomited one time on 05 October 2006. He was seen in the physician's office the following day, on 06 October 2006, and had experienced loose stools two times that morning, with one episode of vomiting. Reportedly, two days later, on 08 October 2006, the patient presented with a four day history of diarrheal stool which looked rusty colored. It was noted that the patients mother could not exclude blood in the stool and the patient was admitted to the hospital. The following day, on 09 October 2006, the patient had ad differential diagnosis of viral illness (possibly from the Rotateq vaccine), bacterial enteritis, and intussusception. Diagnostic urinalysis showed pH 5.0 SP GR 1010, trace protein, no glucose, ketones, leukocytes, blood NHT, no culture. Laboratory work showed lymphocyte 37.0, serum blood urea 24, serum granulocytes 7.66, segmented neutrophil 47.0, CSF monocyte count 11.0. The patien Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: 09 October 2006 abdominal X ray no evidence of obstruction. Diagnostic urinalysis pH 5.0 SP GR 1010, trace protein, no glucose. Laboratory work showed Lymphocyte 37.0, Serum blood urea 24, serum granulocytes 7.6, segmented neutrophil 47.0,


Page 120
Days 1
State FL
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Dyspnoea, Myalgia, Pyrexia
Symptom Text: Information has been received from a physician concerning a 16 year old female who on 10/3/06 was vaccinated with 0.5ml of HPV. On 10/4/06, the pt developed muscle aches, fever and shortness of breath. The pt went to the ER. It was unknown if the pt was hospitalized. At the time of this report, the outcome of the event was unknown. The physician considered the events to be serious as other important medical events (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 121
Onset Date Unknown
Days
State NJ
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Injection site pain
Symptom Text: Information has been received from a physician assistant concerning an 18 year old female with on 8/30/06 was vaccinated with the first dose of HPV (lot 653650/0702F). The physician assistant reported that the pt received the first dose of HPV, about 12 days ago, and she still experiencing injection site pain. The pt sought unspecified medical attention. It was reported that the pt was being treated with ibuprofen (Advil). At the time of this report, the pt had not recovered from the event. The reporter considered the event to be serious as an other important medical event (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 122
Vaers Id: 264696-1 Age Gender F Unknown VAX Detail: Type TTOX HPV4
Days 0
State NH
Mfr Report Id WAES0609USA07424 Route Unknown Intramuscular
Prev Doses
ER VISIT, OMIC, SERIOUS Injection site pain, Medication error
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) with on known allergies or adverse drug reactions reported. On 9/27/06, the pt was vaccinated IM in the left deltoid with 1 ml (2 vials) of HPV vaccine (lot 0B37F). Concomitant therapy included a tetanus toxoid shot in the other arm. Subsequently, the pt experienced arm hurting. The registered nurse confirmed that the pain was at the injection site. The pt has not mentioned any other symptoms. The pt sought unspecified medical attention. The intervention to prevent serious criteria was 800 mg, of Motrin. The registered nurse reported that she did not know if the event would have worsened or improved without the intervention of Motrin. On 9/28/06, the pt returned to the physicians office and was fine, however her arm still hurt. At the time of this report, the pt had not recovered from the event. The reporter considered the event to be serious as an other important medical event (OMIC). Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 123
Related reports: 264703-2 Vaccine Date Onset Date 11-Oct-2006 12-Oct-2006 Manufacturer MERCK & CO. INC.
Days 1
State MA
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Acne, Rash
Symptom Text: Rash/Pimple like on fact and neck. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Ortho tricylen


Page 124
Days 0
Received Date 16-Nov-2006
State MA
Lot Prev Doses 635978/0955F 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Pain, Rash
Symptom Text: Information has been received from a health professional concerning a 21 year old Caucasian female with no known allergies who on 11-OCT-2006 at 9:00 was vaccinated with a first dose of HPV rL1 6 11 15 18 VLP vaccine (yeast), intramuscularly in the deltoid. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 11-OCT-2006 at 9:00 a.m. the patient experienced "face/neck rash, pimple like stinging." It was reported to be unknown if the patient recovered. ORTHO TRI-CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None UNK


Page 125
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
Symptom Text: Initial and follow up information has been received from a physician and a registered nurse in the physicians office concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. The physician reported that the pt experienced soreness, pain at injection site after receiving HPV. The registered nurse reported that she had spoken with the physician who felt that the soreness was not really a reaction or a problem. It was reported that the physician did not feel it was an adverse effect, just soreness at the injection site. At the time of this report, the outcome of the event was unk. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 126
Days 10
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Fungal infection, Pruritus genital, Vaginal infection
Symptom Text: Information has been received from a licensed practical nurse concerning a 13 year old female with diabetes and no known adverse drug reactions or allergies reported. On 8/30/06, the pt was vaccinated IM with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F). Concomitant therapy included insulin. On 9/9/06 the pt developed a yeast infection. It was reported that the pt had vaginal itching since receiving HPV It was reported that the pt underwent a vaginal swab which came back positive for yeast. The pt was being treated with Monistat. the pt was treated with the over the counter medication and was not required to follow up with the physician at this time. According to the licensed practical nurse, the physician did not feel that HPV was the cause of the yeast infection and that it was the pts mother who inquired about the event. At the time of this report, the pt had recovered from the yeast infection (date unk). No further information is available. Insulin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Vaginal gram stain vaginal swab came back positive for yeast. Diabetes


Page 127
Days 0
State CA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Infection, Injection site mass, Injection site reaction, Pruritus
Symptom Text: Information has been received from a 42 year old female with hypersensitivity to SOMA and a history of two pregnancies, and two unspecified abortions who on 9/5/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Lasix and Wellbutrin. The pt reported that on 9/5/06 she developed an injection site reaction. The pt reported that the reaction was like straph infection and described the reaction as looking like and itching like a big mosquito bite. The pt had not yet contacted her physician. At the time of this report, the pt had not yet recovered from the injection site reaction. No further information is expected. Wellbutrin, Lasix Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Abortion, Pregnancy, Drug hypersensitivity.


Page 128
Onset Date Unknown
Days
State ND
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Symptom Text: Information has been received from a licensed practical nurse concerning a female pt who on an unspecified date was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently the pt experienced pain, numbness, and at tingly feeling all the way down to her fingertips. The events occurred in the arm in which the pt received the vaccination. Unspecified medical attention was sought. The pt subsequently recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 129
Days 0
State MD
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia
Symptom Text: Information has been received from a physician concerning a 22 year old female pt who on 9/12/06 was vaccinated IM into the upper left buttock with a dose of HPV rL1 6 11 16 18 VLP vaccine yeast, lot 653650/0702F. there was no concomitant medication. Approx one hour post vaccination the pt experienced numbness and tingling on the right side of her face. medial attention was sought. No other symptoms were noted. As of the report date, the pt was recovering. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 130
Days 1
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Feeling abnormal, Headache, Malaise, Mydriasis
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female with syncope, anxiety and no known allergies reported. On 9/11/06, the pt was vaccinated IM with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Lexapro, Wellbutrin, Klonopin, Nicomide, and Zithromax. On 9/12/06 when the pt woke up, she complained of her pupils being dilated, a headache, light headed and reported that she feels like something in not quite right. It was reported that it was unknown if the pt had eaten that day. The pt sought unspecified medical attention. At the time of this report, the pt had not recovered from the events. Additional information has been requested. Zithromax, Wellbutrin, Klonopin, Lexapro, Nicomide, Minocycline. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Syncope, Anxiety.


Page 131
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Nausea, Vomiting
Symptom Text: Information has been received from a pharmacy intern concerning a female who on 9/12/06 the pt experienced nausea and vomiting. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unk. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 132
Days 6
State ME
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Unintended pregnancy, Viral infection
Symptom Text: Information has been received through the pregnancy registry from a nurse practitioner concerning a 15 year old female with no known drug allergies, and with depression who on 8/31/06 at 3:00pm was vaccinated IM in the right deltoid with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F). Illnesses at the time of vaccination included flu symptoms and a breast lump. Concomitant therapy included sertraline HCL (Zoloft). Other vaccinations given on 9/6/06 included diphtheria toxoid + pertussis acellular vaccine (unspecified) + tetanus toxoid. On 9/6/06 the pt was seen at her physician with a complaint of continued viral illness. It was reported that the pt was aware that she was pregnant but did not disclose this information to her health care provider until after vaccination. A urine pregnancy test was performed and found to be positive. The pt was advised no to receive the second dose of HPV. At the time of this report, the outcome of the viral illness and vaccine exposure during pregnancy was not known. Additional information has been requested. Zoloft Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Urine beta human 09/06/06 positive. Pregnancy, breast lump, flu symptoms. depression. Breast lump, Flu symptoms


Page 133
Days 0
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Rash maculo-papular
Symptom Text: Information has been received from a physician concerning a female patient who on 11-SEP-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician reported that within 24 hours of receiving the vaccine the patient developed a maculo papular rash all over the body. Medical attention was sought. The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 134
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practioner concerning her 20 year old daughter who on an unspecified date was vaccinated with 0.5 mL of HPV rL1 6111618 VLP vaccine (yeast). It was reported that "right after she got it", the patient developed severe arm pain (date unknown). The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 135
Days 1
State IN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pain, Pyrexia
Symptom Text: Initial and follow up information has been received from a physician concerning a 20 year old female patient with sulfonamide allergy who on 12-SEP-2006 at 13:45 p.m. was vaccinated IM in the left deltoid with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot #653650/0641. Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (MICROGESTIN FE). On the early morning of 13-SEP-2006 the patient developed a fever to 103.6 degrees F, and generalized body aches. Medical attention was sought. On 18-SEP-2006, the patient recovered. Additional information is not expected. MICROGESTIN FE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Body temp 09/13/06 103.6 degr Sulfonamide allergy


Page 136
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Malaise, Syncope
Symptom Text: Information has been received from a nurse practioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, the patient fainted post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection". Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 137
Days 0
Received Date 17-Oct-2006 Lot UNK
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Fatigue, Headache, Nausea
Symptom Text: Information has been received from a 28 year old female patient with epilepsy, asthma and an allergy to carbamazepine (TEGRETOL) who on 18-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO), lorazepam, "lomectol," zolpidem tartrate (AMBIEN), and fluticasone propionate (FLOVENT). The patient stated that since her vaccination she has been experiencing dizzy, tired, has headaches and felt nauseous. No medical attention was sought. As of the report date the patient has not recovered. Additional information has been requested. (therapy unspecified), LEXAPRO, FLOVENT, lorazepam, AMBIEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Concurrent conditions: epilepsy, asthma, drug hypersensitivity.


Page 138
Onset Date Unknown
Days
Received Date 17-Oct-2006 Lot UNK
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pyrexia
Symptom Text: Information has been received from a licensed practical nurse concerning a female patient with sulfonamide allergy who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced a fever for four days. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Concurrent conditions: sulfonamide allergy


Page 139
Days 1
Received Date 17-Oct-2006
State PA
Lot Prev Doses 653735/0688F
Site Unknown
ER VISIT, NOT SERIOUS Pyrexia, Rash vesicular
Symptom Text: Information has been received from a physician concerning a 17 year old female with no history of varicella virus vaccine live vaccination and an unknown history of varicella, who on 11-SEP-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The physician reported that on 12-SEP-2006 "the next day, the patient developed a low grade fever and a vesicular rash on her neck and shoulders of about 15-20 lesions." The patient was treated with acetaminophen (TYLENOL). All of her symptoms resolved within 3-4 days (approximately 15-SEP-2006). Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 140
Onset Date Unknown
Days
State MD
Prev Doses
Site Unknown
Symptom Text: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 141
Days 1
State --
Site Unknown
Symptom Text: Information has been received from a medical assistant concerning a 25 year old female with connective tissue disorder, thrombocytopenia, depression and allergy to ZITHROMAX who on 20-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) IM in the deltoid described as "pre-filled syringe one time." Concomitant therapy included escitalopram oxalate (LEXAPRO) and methylphenidate HCl (RITALIN). On 21-SEP-2006 the patient experienced fever of 100 degrees F. The patient sought unspecified medical attention. The patient's fever of 100 degrees F. persisted. Additional information has been requested. LEXAPRO, RITALIN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Concurrent conditions: connective tissue disorder, thrombocytopenia, depression, drug hypersensitivity


Page 142
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site reaction
Symptom Text: Information has been received from a nurse practitioner concerning a female who on 18-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced injection site reaction. The patient sought unspecified medical attention. Injection site reaction persists. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 143
Days 7
State MO
Site Unknown
ER VISIT, NOT SERIOUS Injection site rash
Symptom Text: Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered. hormonal contraception Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 144
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Rash pruritic, Rash vesicular
Symptom Text: Information has been received from a pharmacist concerning a female patient (age not reported) a physician mentioned who was vaccinated on an unspecified date with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient developed a poison ivy-like rash on her shoulder behind the area where she was administered the vaccine. The rash was reported to be itchy, vesicular and the size of a grapefruit. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 145
Onset Date Unknown
Days
State FL
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Oedema peripheral
Symptom Text: Information has been received from a physician concerning a 21 year old female who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient developed "swelling feet" for an unspecified amount of time after receiving the injection. At the time of this report the patient was recovering. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 146
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site inflammation, Injection site pain
Symptom Text: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient experienced burning and pain at the injection site. Unspecified medical attention was sought. It was unknown at the time of the report if the patient had recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 147
Vaers Id: 264761-1 Age Gender F 18.0 VAX Detail: Type TDAP HPV4 Seriousness: MedDRA PT
Onset Date Unknown
Days
State --
Manufacturer GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.
Prev Doses
Symptom Text: Information has been received from a physician concerning his "around 18" year old daughter who was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX). Subsequently, the patient experienced numbness in her arms and lower extremities. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 148
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 26 year old female with a penicillin allergy who on 25-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Immediately post-vaccination, the patient experienced hives. The patient was treated with oral diphenhydramine hydrochloride (BENADRYL) and symptoms lessened. No diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Concurrent conditions: penicillin allergy


Page 149
Days 0
State IN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site swelling, Lymphadenopathy, Pyrexia
Symptom Text: Information has been received from a physician concerning a 17 year old female patient who on 22-SEP-2006 was vaccinated IM with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. On 22-SEP-2006 the patient developed swollen lymph nodes in the neck and groin, swelling at injection site and low grade fever. The patient sought unspecified medical attention. It was reported that the patient was recovering. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 150
Days 1
State FL
Prev Doses
ER VISIT, NOT SERIOUS Injection site mass
Symptom Text: Information has been received from a 28 year old female who on approximately 26-AUG-2006 was vaccinated intramuscularly in her right buttocks with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). On approximately 27-AUG-2006 the patient developed a painful lump in the area of her injection site. She stated "there is a ball inside my skin and it still occasionally hurts." Subsequently, unspecified medical attention was sought. At the time of this report the patient had not recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 151
Onset Date Unknown
Days
State WY
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 152
Onset Date Unknown
Days
State MD
Prev Doses
Site Unknown


Page 153
Onset Date Unknown
Days
State MD
Prev Doses
Site Unknown


Page 154
Onset Date Unknown
Days
State MD
Prev Doses
Site Unknown


Page 155
Onset Date Unknown
Days
State MD
Prev Doses
Site Unknown
Symptom Text: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 156
Onset Date Unknown
Days
State MD
Prev Doses
Site Unknown


Page 157
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician's office concerning a female patient was was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The reporter indicated that using the prefilled syringe was "painful and startling" to the patient. Her outcome was not reported. A product quality complaint was not involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 158
Days 1
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Oedema peripheral, Pruritus
Symptom Text: Information has been received from a 27 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 27-SEP-2006, the patient was vaccinated with 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (reported as "birth control"). On 28-SEP-2006, the patient developed red, itchy and swollen hands and feet. The patient sought unspecified medical attention. At the time of this report the patient was recovering from the events. Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 159
Days 0
State PA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pain, Nausea, Pain
Symptom Text: Information has been received from the mother of a female patient in her "early 20's" with no relevant medical history who on 25-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 mL). There was no concomitant medication. On 25-SEP-2006, the patient experienced "a lot of pain and nausea." The pain was described as a stinging feeling when the medication was being injected. The patient subsequently recovered from the pain and nausea one hour after vaccination. Medical attention was not sought. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 160
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Medication error, Pain
Symptom Text: Information has been received from a nurse practitioner concerning a 23 year old female with mild cervical dysplasia with colposcopy and no known allergies or adverse drug reactions reported. On 26-SEP-2006, the patient was vaccinated with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication reported. It was reported that the pre-filled syringe had been stored at 34F. On 26-SEP-2006 the patient developed severe pain during administration with lightheadedness and dizziness. The patient was laid on the exam table and given ibuprofen (MOTRIN) for pain. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Concurrent conditions: cervical dysplasia, colposcopy


Page 161
Onset Date Unknown
Days
State CO
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Medication error, Myalgia
Symptom Text: Information has been received from a registered nurse concerning a 25 year old female who in 2006 (date not reported) was vaccinated with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The nurse reported having "the syringe jam and could not administer the vaccine." The vaccine was given using a second syringe. The nurse also reported that the patient experienced "muscle pain in her arm, the arm of the jammed syringe." At the time of this report, the patient had not recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 162
Days 0
State MO
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Chills, Pyrexia
Symptom Text: Information has been received from a physician concerning an 18 year old female patient who in September 2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently in September 2006 the patient developed 102 degree temperature and chills. Medical attention was sought. The patient was recovering. Additional information has been requested. UNK Other Meds: Body temp, 09/??/2006, 102 degrees F Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 163
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
Symptom Text: Information has been received from an LPN concerning a female patient who was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in her arm in excess of 5 days. There was no swelling or rash, only the pain. Medical attention was sought. The pain was reported to have improved on therapy. It was unknown whether this was an injection site reaction. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 164
Onset Date Unknown
Days
State ND
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Injection site pain, Paraesthesia
Symptom Text: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 165
Onset Date Unknown
Days
State ND
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Pain, Paraesthesia
Symptom Text: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 166
Onset Date Unknown
Days
State ND
Prev Doses
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 167
Onset Date Unknown
Days
State ND
Prev Doses
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been sought. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 168
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Headache, Pyrexia
Symptom Text: Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Within 1 to 2 days after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 169
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning an 11 year old female patient who on an unspecified date was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Within one to two days after administration, the patient developed headache and fever. No medical attention was sought. Her outcome was not reported. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 170
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown


Page 171
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown


Page 172
Days 7
State MO
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site reaction
Symptom Text: Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered. Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 173
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient developed headache and fever. Her outcome was not reported. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 174
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient developed headache and fever. Her outcome was not reported. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 175
Onset Date Unknown
Days
State WY
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. The patient had to lie down for a short time period until the pain subsided. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 176
Onset Date Unknown
Days
State WY
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 177
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Malaise, Syncope
Symptom Text: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection." Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 178
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 179
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 180
Vaers Id: 264950-1 Age Gender F 57.0 VAX Detail: Type MMR HPV4
Days 14
Received Date 19-Oct-2006 Lot 0296R 0039F
State WI
Mfr Report Id Route Subcutaneously Intramuscular
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Chest pain, Hypoaesthesia, Lymphadenopathy
Symptom Text: 09/19/2006 MMR and HBV adm 1, 10/03/2006 swollen glands, numbness and tingling of arm and legs bilat. Pt called hotline and states she was told this was from the MMR. 10/15/06 chest pain. Pt wonders if this is related to immunizations. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Valve Proplase in distant past, neg heart cath 2 yrs ago. NONE


Page 181
Days 0
Received Date 19-Oct-2006 Lot 0955F 0741F
State CT
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Bradycardia, Coma, Heart rate irregular, Musculoskeletal stiffness, Pallor, Syncope, Urinary incontinence
Symptom Text: Administr4ed Vaqta, then Gardasil, immediately after Gardasil child became unresponsive, stiff, pale about 30 sex. Child lost bladder control, pulse 46-55 after event, child alert and aware after events. 11/27/06 Received medical records from provider/reporter which reveal patient had LOC,tonic/clonic movements & loss of bladder control after received 2nd Gardisil vax. HR was 46-55. This was the 3rd episode of LOC within a year (1st after tetanus shot, 2nd after finding a tick & 3rd after 2nd dose of Gardisil). PCP recommended cardiac & neuro w/u. Received cardiac consultation which revealed final dx: probable fainting. Holter monitor was WNL. Awaiting neuro consult. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Scheduled for cardiac and Neuro follow up. LABS: IgG was only positive for Lyme dx which was considered negative.


Page 182
Related reports: 264992-2 Vaccine Date Onset Date 16-Oct-2006 18-Oct-2006 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Days 2
Received Date 19-Oct-2006 Lot C2572AA 0637F
State CA
Prev Doses
NO CONDITIONS, NOT SERIOUS Blister, Face oedema
Symptom Text: Received Tdap and HPV vaccine on 10/16/2006 noticed some blisters at the corner of mouth and swelling of lower lip on the evening of 10/18/2006 and facial swelling around eyes on 10/19/06. No fever, headache, dizziness or any GI symptoms. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 183
Vaers Id: 264992-2 Age Gender F 15.0 VAX Detail: Type HPV4 DTAP
Related reports: 264992-1 Vaccine Date Onset Date 16-Oct-2006 16-Oct-2006
Days 0
State CA
Lot Prev Doses 653937/0637F NULL
ER VISIT, NOT SERIOUS Hypersensitivity, Hypersensitivity, Swelling
Symptom Text: Information has been received from a business manager in a physicians office concerning a 15 year old female who on 16 Oct 2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine. Concomitant therapy that day included diphtheria toxoid + pertussis acellular vaccine + tetanus toxoid. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of diphenhydramine hydrochloride (Benadryl). After taking diphenhydramine hydrochloride the patients face and body swelling "went down". On 20 Oct 2006 it was reported that "the swelling became worse again". At the time of this report the patient had not recovered from the event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 184
Days 7
State KY
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Headache, Injection site reaction, Pruritus, Thermal burn
Symptom Text: Localized reaction at injection site right del itching and burning beginning 7 day post injection, also headache. Txd symptoms with Benadryl, Tylenol, Hydrocortisone cream. Lexapro, Effexor, Yasmin, HCTZ, Elmiron, Parida Plus, Claritin. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sulfa Allergy, Hypertension, Intestinal cystitis.


Page 185
Days 0
State --
Prev Doses
Site Unknown
OMIC, SERIOUS Asthenia, Dizziness, Hyperhidrosis
Symptom Text: After receiving Gardasil vaccine #1 pt immediately became lightheaded, weak and sweaty. SX lasted approx 5 minutes. (OMIC). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 186
Days 0
Received Date 24-Oct-2006 Lot UNKNOWN
State FL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Difficulty in walking, Muscle rigidity, Syncope
Symptom Text: According to my daughter, the following happened: 1. Shot was given between 1100-1115 am 2. Proceed to wait a few minutes with doctor in room and then went to check out 3. Between 1120-1125 am...she passed out in doctors office. 4. Day 2-4: tightness in muscles especially around lower legs. Also tigtness in arms, but not as bad as legs. 5. Hard time walking after first waking up in morning and gradually loosens up after she starts moving around. 6. I suggested to her to take a Tylenol to help with muscle tightness and to massage calves prior to getting out of bed to help loosen them up. Ortho-tricyclene Low Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: N/A None None.


Page 187
Vaers Id: 265338-1 Age Gender M 1.0 VAX Detail: Type PNC FLU HEPA HPV4 HIBV Seriousness: MedDRA PT
Onset Date Unknown
Days
Received Date 25-Oct-2006 Lot B22930D V2175HA AHAVB099CB 0688F 0212R
State MI
Mfr Report Id Route Intramuscular Intramuscular Intramuscular Intramuscular Intramuscular
Manufacturer LEDERLE LABORATORIES AVENTIS PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC.
Site Left leg Unknown Unknown Unknown Unknown
Symptom Text: None Stated Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 188
Days 7
State KY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: Approximately 7 days after HPV IM, L deltoid became very sore, painful to abduct. Nosig soreness at 24 hours after IM. On exam is tender deep in muscle and is enlarged. No surface redness. No induration. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none


Page 189
Vaers Id: 265372-1 (S) Age Gender Vaccine Date F 06-Oct-2006 24.0 VAX Detail: Type HPV4
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Eye swelling, Pruritus, Vision blurred
Symptom Text: Information has been received from a physician concerning a 24 year old female pt with no known allergies or reportable medical history who on 10/6/06 was vaccinated IM with a 0.5ml dose of HPV. Several hours later, on 10/6/06 the pt called the office with complaints of swollen puffy eyes, some itching but no rash and blurry vision. The pt was seen in the office that evening on 10/6/06 and was given a dose of Benadryl and was sent home. The pt took a nap for the blurry vision and upon awakening the next morning the pt fully recovered. Blurry vision was considered to be disabling according to the physician since the pt was unable to perform her normal task. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 190
Days 0
Received Date 26-Oct-2006 Lot 0966P
State --
Prev Doses
Site Unknown
OMIC, SERIOUS Asthenia, Dizziness, Hyperhidrosis, Syncope vasovagal
Symptom Text: Few minutes after receiving Gardasil vaccine patient had vaso vagal type reaction, weak, dizzy, hot, sweaty. Felt like she was going to faint. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 191
Days 0
State PA
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Acne
Symptom Text: Papules used BENADRYL and cortisone. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 192
Days 5
State NC
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Anxiety, Cough, Hypersensitivity, Hypoaesthesia, Psychomotor hyperactivity, Pyrexia
Symptom Text: Fever, cough, numb, and tingling all over, acted hyperactive loopy, taking OTC cold remedies, MD suggested Claritin and nasal spray for allergies, may need anti anxiety and anti depressant for ADHD, anxiety. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Thyroid, Potassium levels done. Given flu vaccine 10/27/06 NONE NONE


Page 193
Days 2
Received Date 01-Nov-2006 Lot 0702F
Status Date 02-Nov-2006 Site Left arm
State MO
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Hypoaesthesia
Symptom Text: Patient complained of Left arm numbness after receiving injection. Lasted less than 48 hours. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Depression & Anxiety, Migraine Headaches, Acne, Exzema, Seasonal Allergies. none Doxycycline,Zoloft,Yasmin


Page 194
Days 0
Received Date 01-Nov-2006 Lot NULL
State WA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Vomiting
Symptom Text: Patient reports she vomited 1 time approximately 4 hours following injection of Gardasil. Patient's mother reports that the patient vomited following the first injection in series. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 195
Days 1
State MD
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Chills, Nausea, Pyrexia, Vomiting
Symptom Text: Nausea and vomiting, fever 99 degrees F- 100 degrees F, chills for 3 days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: allergic to Penicillin. NONE Estrostep


Page 196
Days 1
State MD
Site Unknown
Symptom Text: Information has been received from a physician concerning a 21 year old female with an allergy to penicillin who was receiving contraceptive therapy, who on 06-OCT-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 mL). Concomitant therapy included ethinyl estradiol/norethindrone acetate (ESTROSTEP). On 07-OCT-2006 or 08-OCT-2006 the patient experienced nausea and vomiting. Unspecified medical attention was sought. Subsequently, the patient recovered from the nausea and vomiting. Additional information has been requested. ESTROSTEP Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Concurrent conditions: penicillin allergy


Page 197
Vaers Id: 265839-1 (S) Related reports: 265839-2 Age Gender Vaccine Date Onset Date F Unknown 09-Oct-2006 16.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days
State OH
Prev Doses 0
Site Unknown
HOSPITALIZED, SERIOUS Asthenia, Guillain-Barre syndrome, Hypoaesthesia
Symptom Text: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with the first dose of HPV vaccine. subsequently the pt developed lower extremity weakness and was hospitalized for two days with Guillain Barre. The pt received treatment with gamma globulin during her hospitalization. At the time of this report, the pt was back to school and was 99% recovered having only some area of numbness to her lower extremities. The physician did not believe that the pt was on any other medications at the time and had no further details to provide. Additional information has been requested. Mild Guillane Barre Syndrome. EMG study on 10/10/2006: nerve conduction studies of right peroneal and tibial nerves were normal. F wave latencies were normal but some blocking was present. Conclusion: study consistent with mild Guillain Barre Syndrome. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 198
Days
State OH
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Guillain-Barre syndrome, Neuropathy, Pain
Symptom Text: Information has been received from a neurologist concerning a female pt who was vaccinated with one dose of HPV vaccine. Subsequently the pt developed neuropathy and pain in the legs. The pt was diagnosed with Guillain Barre syndrome. The pts Guillain Barre syndrome persisted. Upon internal review, Guillain Barre syndrome was considered to be an other important medical event (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 199
Vaers Id: 265930-1 (S) Age Gender Vaccine Date F 23-Sep-2006 Unknown VAX Detail: Type HPV4
Days 14
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Encephalitis
Symptom Text: Information has been received from a physician concerning a female who on approximately 9/23/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). On 10/7/06, the patient experienced acute disseminated encephalomyelitis and was hospitalized in a neurology ward of a children's hospital. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 200
Vaers Id: 265955-1 Age Gender F 13.0 VAX Detail:
Days 0
Received Date 03-Nov-2006 Lot NULL NULL
State CA
Mfr Report Id Route Subcutaneously Unknown
Type VARCEL HPV4
Prev Doses 1
Site Right arm Unknown
NO CONDITIONS, NOT SERIOUS Hypoaesthesia, Injection site pain, Syncope
Symptom Text: Per pt arm where Gardasil was administered felt painful then numb and then pt fainted for a few seconds. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 201
Days 0
State WV
Prev Doses 0
Site Right arm
Symptom Text: Complaints of pain in right arm initially after 1st Gardasil injection. States right arm hurt for 1 month after shot was given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 202
Days 3
State CA
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Pruritus, Urticaria
Symptom Text: Information has been received from a physician and the mother of a 15 year old female with a history of hypersensitivity reactions to allergens. On 10/3/06, the pt was vaccinated IM with the first dose of 0.5ml of HPV vaccine (lot 653650/0702F. Concomitant therapy included Ortho Tri Cyclen LO started on 10/6/06. On 10/06/06, the pt developed widespread itching and hives of both upper and lower extremities. The pt did not experience respiratory symptoms. The pt was self treated with Benadryl with only mild improvement. A nurse in the local ER was consultated by phone but the pt did not require hospitalization. The symptoms resolved after one week and the pt had not experienced further problems. On 10/13/06 the pt had recovered from the event. The physician considered the event to be serious as disabling. Additional information has been requested. Ortho Tri Cyclen LO Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Hypersensitivity.


Page 203
Days 0
State IN
Prev Doses 0
ER VISIT, NOT SERIOUS Disorientation, Dizziness, Dyspnoea, Nausea, Syncope
Symptom Text: Patient fainted in waiting area less than five minutes after receiving Gardasil injection. Patient disoriented and c/o difficulty breathing when roused. C/O nausea, dizziness. Sent to ER & diagnosed as vasovagal syncope. Patient c/o sores in genital area 3 days post vaccination. Upon visit to doctor, diagnosed with Condyloma. Advil, Benadryl, Tylenol Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 204
Days 0
Received Date 18-Dec-2006 Lot 0955F
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Syncope vasovagal
Symptom Text: Information has been received from a registered nurse concerning a 17 year old white female (121 pounds, 61.5 inches) who on 30 Oct 2006 was vaccinated with Gardisil (lot number 653978/0955F) intramuscularly. On 30 Oct 2006, after the injection , the patient left the examination room and arrived in the lobby (noted as less than 2 minutes) when the nurse was called to the lobby. The patient's mother stated the patient "passed out" for a few seconds. It was also noted that the patient was "faint" with a duration of less than 1 minute, had dizziness which lasted approximately 1.5 hours, had nausea for approximately 15 minutes, and her skin was clammy. The patients blood pressure and pulse were within normal limits. A cold wash cloth was applied to the patients neck. The patient was taken by wheelchair to the Emergency Department. The patient's mother reported that the Emergency Department visit was quick and the physician stated that the patient had a vasovagal response. On 31 Oct 2006, the patient was considered recovered from vasovagal response. Additional information is not available. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 205
Days 1
Received Date 10-Nov-2006 Lot 0702P
State KY
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Angioneurotic oedema, Face oedema
Symptom Text: Angioedema lips for one month by history from pt. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 206
Days 0
State WV
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Irritability, Rash
Symptom Text: Fussy body rash X 24 hours following vaccination. Cleared spontaneously. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 207
Vaers Id: 266581-1 Age Gender F 19.0 VAX Detail: Type HPV4 FLU
Days 0
Received Date 13-Nov-2006 Lot 0688F U2165CA
State VA
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 0 2
NO CONDITIONS, NOT SERIOUS Blood pressure decreased, Bradycardia, Heart rate irregular
Symptom Text: Vasovagal RXN. Pt HR decreased to 50 and BP decreased. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allegra, Nasolcrom, Acne meds, Bactrim Skin prick tested for allergies. Acne, allergies to raw peaches, carrot, potatoes, kiwi, apples, cherries. NONE Fever~DTP (unknown mfr)~1~1~In Patient


Page 208
Vaers Id: 266592-1 Age Gender F 11.0 VAX Detail: Type TDAP HPV4 FLU Seriousness: MedDRA PT
Onset Date 01-Nov-2006
Days 1
Received Date 13-Nov-2006 Lot AC52B011CA 0955F U2199AA
Status Date 12-Dec-2006 Site Left arm
State PA
Manufacturer GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 5 0 4
Right arm Right arm
NO CONDITIONS, NOT SERIOUS Erythema, Rash, Rash papular
Symptom Text: Fine red, papular, pruritic rash on 1st and 2nd digits both hands and dorsum both feet. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 209
Vaccine Date 08-Nov-2006
Days 0
Received Date 13-Nov-2006 Lot U1808AA 0688F
State ME
Last Edit Date 12-Dec-2006 Other Vaccine FLU HEPA
Prev Doses 0 0
ER VISIT, NOT SERIOUS Erythema, Swelling, Tenderness
Symptom Text: 10.4 cm X 7.0 cm area of redness. Swelling and tenderness. Complain of burning at site left deltoid. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CONCERTA 54mg Attention-deficit Hyperactivity disorder NONE


Page 210
Days 5
State IL
Prev Doses
Site Unknown
Symptom Text: Developed rash all over body gradually subsided after few days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Ovcon NONE


Page 211
Days 3
State CA
Prev Doses 0
Site Unknown
Symptom Text: Hives all over 3 days after injection. No treatment. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 212
Days 7
State LA
Prev Doses 0
ER VISIT, NOT SERIOUS Injection site pain, Shoulder pain
Symptom Text: Patient developed left shoulder pain at the deltoid corresponding to the site of injection. This began about 1 week after injection and has lasted for 3 weeks. It is 7/10 in severity and requires anti-inflammatories. Yaz, Zoloft, Bactrim DS Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none Depression None


Page 213
Days 0
State OR
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Fatigue, Panic reaction
Symptom Text: Patient c/o: dizziness, lightheaded, feels as if she is going to have a panic attack, very fatigued. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: odd cough & migranes per patient history Advair n/a


Page 214
Vaers Id: 266889-1 (S) Age Gender Vaccine Date F 25-Oct-2006 14.0 VAX Detail: Type TDAP MNQ FLU HPV4 Seriousness: MedDRA PT
Days 1
Received Date 16-Nov-2006 Lot AC52B012AA U1948AA U2256AA 0955F
State MI
Manufacturer GLAXOSMITHKLINE BIOLOGICALS AVENTIS PASTEUR AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses 0 0 0
Site Unknown Unknown Unknown Unknown
HOSPITALIZED, SERIOUS Dehydration, Hypersensitivity, Muscle spasms, Pyrexia
Symptom Text: Pt received injections 10/25/06. Flu and HPV in one thigh. Tdap and Menactra in other thigh unk which thigh each given. Pt then went to allergist and received allergy injection in each arm. Admitted 10/26/06 for fever 103, dehydration and muscle cramping, sent home 10/27/06. DC DX: allergic reaction. 2 day history of fever. On same day as immunizations she received routine allergy shots. Immunizations received in thighs and allergy injections in arms. Complained of arms puffed and welted evening prior to admission, became painful. Also blotchiness on legs. Complained of pain in legs. Headache since immunizations, myalgias and arthralgias especially to shoulder area. Neck pain, prickly sensaton in feet. Previous immunization reacion 3 weeks ago with pain and symptomatic problems. PMH: environmental allergens. Eczema. Roavirus at age 2 months. PE: Extremities, there is injection site visible. No rash, erythema or exudate noted around the injection sites. No other rashes. Nasocort, Zyrtec, Allergy injections. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Labs: Glucose 118, CO2 21, C-reactive protein 1.8. Allergic Rhinitis. PMH: environmental allergens. Eczema. Roavirus at age 2 months.


Page 215
Days 0
State PA
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Disorientation, Dyskinesia, Eye movement disorder, Pallor, Syncope
Symptom Text: Within a minute of giving injection in rt deltoid, pt experienced pallor, syncope, rolling back of the eyes followed by jerky movements of upper & lower extremities. After 5 seconds, she became responsive, but disoriented to place. Pt stated that she had not eaten much all day. Adderall XL 30mg q day Depo Provera 150mg q 3 months Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none NKA none none


Page 216
Vaers Id: 267080-1 (S) Age Gender Vaccine Date F 31-Aug-2006 19.0 VAX Detail: Type HPV4
Days 33
State FL
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, OMIC, SERIOUS Abdominal pain, Feeling cold, Haemorrhage, Hot flush, Nausea, Pyrexia
Symptom Text: concerning a 19 year old female with diabetes and hypothyroidism on 8/31/06 was vaccainted IM with a first dose of HPV vaccine. Concomitant therapy included an insulin pump, Levothyroxine (Synthroid) and (Loworval). On 10/3/06 (also reported as a month later), the pt experienced hot flushes and cold flashed, nausea, a temp less than 100F and abnormal bleeding. On 11/4/06, the pt experienced right lower quadrant abdominal pain and was hospitalized. She has had a CAT scan, MRI, laparoscopy and a few ultrasounds of the area but all have been neg. The pt was treated wit IV fluids. At the time of this report, the pt had not recovered. No product quality complaint was involved. Right lower quadrant abdominal pain was considered to be an other important medical event (OMIC). Additional information has been requested. Insulin, Synthroid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Diabetes, Hypothyroidism.


Page 217
Days 0
State MN
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Pruritus
Symptom Text: Pt received vaccination early in AM. Called later that afternoon and was itching all over. took Benadryl which helped. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE Nuvaring, Allegra D, Albuterol, Nasonex


Page 218
Days 1
Received Date 17-Nov-2006 Lot 08668F U2244AA
State MN
Prev Doses 0 1
ER VISIT, NOT SERIOUS Facial palsy, Hypoaesthesia, Pain, Paralysis
Symptom Text: INfluenza vaccine and Human Papilloma VIrus vaccines given November 10 about 11:45 AM. Patient woke up with numbness on right side of face on November 11. Presented to Emergency Room on November 12 with Bells Palsy of right side of face. Unable to move right side of face. Unable to close right eye. Previously healthy, no symptoms on day of vaccine administration. Received MR from pediatrician revealing a healthy 12 year old in for well-child exam. 24 hours after Flu and Gardasil vax. child developed numbness, pain, and inability to move the right side of face. Assessment: Facial Nerve Palsy-unclear etiology. Child was sent by car to Minneapolis Children's ER to be evaluated. ER report received: DX: Bell's Palsy NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 219
Days 1
State WI
Prev Doses 0
ER VISIT, NOT SERIOUS Facial palsy
Symptom Text: Bell's Palsy right occurred 24 hours after injection of Gardasil. Previously healthy. MR received revealing an 18 yr. old in for well-woman exam with only c/o some discomfort in the mastoid area behind her right ear x2 days. The following day she presented with right-sided facial droop. HPI: Pt awoke morning following Gardasil vax. and had difficulty with spitting out her toothpaste. No pain or visual loss. No extremity weakness or paresthesias. Most obvious upon smiling. Able to wrinkle forehead and puff cheeks. Good sensation. Txd with Famvir, Solu-medrol and Refresh Tears. Assessment: Bell's Palsy. ortho tricylic Meds-Ortho Tri-Cyclen Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Lymes, CBC, CRP, CMP, Sed rate. Labs and Diagnostics: All normal. None PMH: None noted except for dysmenorrhea. NKA. Well woman exam. C/o some discomfort in the mastoid area behind her right ear x2 days.


Page 220
Vaers Id: 267288-1 (S) Age Gender Vaccine Date F 29-Sep-2006 25.0 VAX Detail: Type HPV4
Days 1
State MD
Prev Doses 0
Site Unknown
ER VISIT, LIFE THREATENING, OMIC, PERMANENT DISABILITY, SERIOUS Throat tightness, Tongue oedema, Urticaria
Symptom Text: Information has been received from a physicians assistant concerning a 25 year old female who on 9/29/06 was vaccinated with a first dose of HPV vaccine. Concomitant suspect therapy initiated a few days prior included nitrofurantoin (Macrobid) for the treatment of a urinary tract infection (dose not reported). Other concomitant therapy included drospirenone + ethinyl Estradiol (Yasmin). On 9/20/06 the pt called the physicians office to state that she had developed hives. The physicians office referred her to the ER where she was placed on methylprednisolone (Medrol Dosepak). The pt was not hospitalized. On 10/2/06 the pt called the physicians office to report that her tongue was swelling and her throat was closing. The pt was immediately referred to the ER where she was given epinephrine (Epi Pen). The pt was not hospitalized. On 1/04/06 the pt recovered. Hives, tongue swelling and throat closing were considered to be disabling, immediately life threatening and other important medical events (OMIC). The physicians assistant reported that they were not sure if the reactions was to the HPV or the Macrobid. Additional information has been requested. Yasmin, Macrobid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Urinary tract infection


Page 221
Days 9
State GA
Prev Doses 0
Symptom Text: Pruritus - rash began on lower extremities 1.5 weeks following the first vaccine for HPV. The rash then spread to trunk, back and arms over the next week. Rash began as singular lesions which coalesced it places. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Biopsy done on 11/9/06.


Page 222
Days 0
State WA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Medication error
Symptom Text: Initial and follow up information has been received from a nurse practitioner concerning a 25 year old female customer service representative. On 9/18/06, the pt was vaccinated in the right deltoid with the first dose of 0.5ml of HPV vaccine (lot 653937/0637F). There were no other illnesses noted at the time of vaccination. The nurse practitioner reported that the pt was severely obese and when she received the HPV vaccine, the medication dribbled down her arm. It was report that upon removal of the needle, blood tinged fluid flowed from the injection site. The nurse practitioner was unable to estimate the amount but assumed the pt received less than the full dose. The plan was to re inject the pt with a full dose. At the time of this report, the outcome of the events were unk. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Obesity


Page 223
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fatigue, Malaise, Mood swings
Symptom Text: Information has been received from a nurse concerning a 21 year old female with asthma, unspecified drug reaction to Penicillin and Amoxicillin and might have been exposed to papilloma viral infection. On 7/19/06, the pt was vaccinated IM with the first dose of HPV vaccine (lot 653650/0697F). Concomitant therapy included unspecified hormonal contraceptives. Subsequently, the pt experienced fatigue, was sick and had mood swings for two months. It was reported that the pt felt rotten after receiving HPV vaccine. (date unk). The pt sought unspecified medical attention. The pt underwent a test for mononucleosis that came back neg (date unk). It was reported that the pt felt better two weeks before the second dose of HPV was due to be administered (date unk). It was reported that the pt does not want to receive the second and third dose of HPV vaccine. At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Serum Epstein Barr neg Papilloma viral infection, Penicillin allergy, Asthma.


Page 224
Days 0
Received Date 16-Nov-2006 Lot 0688F NULL
State --
Prev Doses
Symptom Text: Information has been received from a physician concerning a 17 year old female pt with on past medical history who on 10/2/06 was vaccainted with a dose of HPV vaccine, lot 653735/0688F. Concomitant therapy included an unspecified flu shot. It was reported that after receiving HPV vaccine, the pt passed out. Medical attention was sought. the pt recovered the same day. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 225
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from physician concerning a 17 year old female with no other pertinent medical history reported and no known allergies or adverse drug reactions reported. On 9/26/06 the pt was vaccainted with HPV vaccine (lot 653735/0688F). There were no concomitant medications reported. Subsequently, the pt passed out after receiving the vaccine. The pt sought unspecified medical attention. On 9/26/06, the pt had recovered from the event. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 226
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an adult pt who was vaccinated with a dose of HPV vaccine. The pt complained of pain while being injected using the pre filled syringe. The nurse reported that another pt did not complain of pain when a normal syringe was used. The nurse suggested the pre filled needles may be dull causing pain during injection. The pts outcome was not reported. A product quality complaint was involved. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 227
Days 0
State TX
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Lymphadenopathy, Pyrexia
Symptom Text: Information has been received from a healthcare professional concerning a 15 year old female student who on 9/14/06 at 3:00 pm was vaccinated in the right hip with her first dose of HPV vaccine, lot 654540/0800F. On 9/18/06 the pt developed low grade fever and swollen glands. Her outcome was unk. The reporter indicated the pt would be evaluated at her next vaccination. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 228
Days 0
State WA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Pruritus
Symptom Text: Information has been received from a registered nurse and a medical assistant concerning a 27 year old female with seasonal allergies, a possible penicillin allergy and had a history of an abnormal Papanicolaou smear and loop electrosurgical excision procedure. On 8/2/06, the pt was vaccinated IM in the arm with the first 0.5ml pre filled syringe dose of HPV Vaccine (lot 653650/0640F). Concomitant therapy included unspecified hormonal contraceptive (reported as birth control pills). Following the first vaccination, the pt did not experience any adverse reactions. On 10/2/06, the pt was vaccinated with the second dose of HPV vaccine. On 10/2/06, 12 hours after the vaccination, the pt woke up in the middle of the night with right red, itchy hands and feet (also reported as soaked them in ice). It was reported that the symptoms were better the afternoon of the vaccination. On 10/3/06, the pt took Benadryl. The pt sought unspecified medical attention. On 10/4/06, the registered nurse spoke with the pt in the afternoon and all symptoms had resolved. The medical assistant note that the pt had no immediate severe symptoms. The medical assistant reported that there was no mention of seriousness of events in the pts chart and reported that the events did not look like they were serious. The registered nurse further reported that she would not classify the events as serious. Additional information has been requested. Hormonal Contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Pap Smear abnormal, Loop electrosurgical excision procedure, seasonal allergy, penicillin allergy.


Page 229
Days 1
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Rash pruritic
Symptom Text: Information has been received from a physician concerning her 18 year old daughter who on 10/01/2006 was vaccinated with HPV vaccine IM in right deltoid. On 10/2/06, within 24 hours, the pt experienced itchy rash on her elbows, feet, buttocks and back. She was given Benadryl and topical steroid cream to treat the symptoms. The pts itchy rash on her elbows, feet, buttocks and back persisted. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 230
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 231
Days 1124
State NY
Prev Doses 2
Site Unknown
NO CONDITIONS, NOT SERIOUS Drug ineffective
Symptom Text: Information has been received spontaneously from a gynecologist concerning a 22 year old female patient who had participated in an HPV study. On 29-SEP2006 the patient tested positive for high risk HPV. The patient's outcome was unknown. Upon internal request, the patient was unblinded on 25-OCT-2006, she received her first dose of HPV on 06-FEB-2003, her second dose in March 2003, and her third dose in September 2003. She showed strong conversion to all 4 vaccine types. At baseline the patient had been seronegative and polymerase chain reaction test (PCR) negative to all 4 vaccine types. In October 2003 she had been PCR negative to all 4 vaccine types. An April 2005 PCR result from a biopsy was negative for the 4 vaccine types. Additional study results: 07-DEC2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choices) were needed per protocol. 21-SEP-2005 low grade squamous intraepithelial lesions (LSIL). 13-OCT-2005 colposcopy cervical intraepithelial neoplasia (CIN) -1. 25-JAN-2006 atypical squamous cell of undetermined significance (ASCUS) (HPV+). 30-MAR-2006 CIN-2. 12-MAY-2006 loop electrosurgical excision procedure (LEEP) = CIN-1 overall. 24-JUL-2006 PAP negative. At this point the patient had completed the study. She went to her own doctor and had another abnormal pap positive HR HPV test. The specific cytological diagnosis and the PCR test reports as positive for high risk type but did not indicate which specific HPV type. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: 07-DEC-2004: "ASC-H". 04-APR-2005 colposcopy biopsy negative for lesion, discrepancy noted - biopsy was of less severity than the Papanicolaou (PAP) test result and repeat colposcopy, PAP, and endocervical curettage (ECC) (among other choic UNK


Page 232
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04385, 0610USA04386 and 0610USA03730). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 233
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experiences (WAES #'s 0610USA04384, 0610USA04386 and 0610USA03730). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 234
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site anaesthesia, Paraesthesia
Symptom Text: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 mL dose of GARDADIL (lot #653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES0620USA04384, WAES0610USA04385 and WAES0610USA03730). Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 235
Days 0
State FL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Contusion, Injection site pain, Pain, Pyrexia
Symptom Text: Information has been received from a 26 year old female medical assistant (not CMA) with migraines, sulfonamide allergy and drug hypersensitivity to over the counter cold medications, who on 27-SEP-2006, was vaccinated IM with a 0.5ml dose of HPV (lot # 653735/0688F). Concomitant therapy included ethinyl estradiol/norethindrone (OVCON 35), netaxalone (SKELAXIN) and acetaminophen/hydrocodone bitartrate (VICODIN TABLETS). On 27-SEP-2006, the patient experienced severe pain at the injection site while the medication was being injected. The medical assistant also reported the pain as a sore bruised feeling that lasted for 4 to 5 days. On approximately 27-SEP-2006, the patient also experienced slight fever for 4 to 5 days. On 04-OCT-2006, she had physical therapy and the sore bruised feeling came back. Subsequently, the medical assistant recovered, however it was unknown if she recovered from the sore bruised feeling that came back on 04-OCT-2006. There was no product quality complaint involved. The patient sought unspecified medical attention. Additional information has been requested. VICODIN TABLETS; OVCON 35; SKELAXIN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Migraine; Sulfonamide allergy; Drug hypersensitivity


Page 236
Days 0
State TN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Hypoaesthesia
Symptom Text: Information has been received from a registered nurse concerning a female patient who on 06-OCT-2006 was vaccinated in the right arm with the first dose of HPV (lot # not provided). On 06-OCT-2006, the patient experienced lightheadedness and numbness in her left arm. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from lightheadedness and numbness in her left arm and was able to leave the office. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 237
Days 0
State CA
Prev Doses
ER VISIT, NOT SERIOUS Muscle spasms, Pain
Symptom Text: Information has been received from a physician concerning a 14 year old female patient who on 05-OCT-2006 was vaccinated IM with a dose of HPV. Concomitant therapy included hepatitis A virus vaccine (unspecified), administered at the same time and in the same arm. The physician reported that the patient was experiencing "severe spasmatic pain in her arm", and that the muscle would tense up for a 5 to 10 minute time frame. An hour later the pain would subside. Medical attention was sought. The patient recovered the next day, 06-OCT-2006. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 238
Days 0
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 25 year old female with anxiety, depression and a lump in her vagina who on 02-OCT-2006 was vaccinated with IM in the upper arm with a 0.5 mL first dose of HPV (lot 653978/0955F). Concomitant therapy included bupropion HCl (WELLBUTRIN XL), diclofenac potassium (CATAFLAM) and paroxetine HCl (PAXIL). On 02-OCT-2006, ten minutes post vaccination, the patient passed out for a few seconds. The patient received unspecified medical attention. Subsequently, on 02-OCT-2006, the patient recovered. Additional information has been requested. WELLBUTRIN XL; CATAFLAM; PAXIL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Anxiety; Depression; Mass UNK


Page 239
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning her 15 year old daughter who was vaccinated with HPV. Subsequently, the patient experienced red dots/rashes on her ankles, elbows, and buttocks. Subsequently, the patient recovered from red dots/rashes on ankles, elbows, and buttocks. Therapy with HPV was not re-introduced. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 240
Vaers Id: 267427-1 Age Gender F 11.0 VAX Detail: Type HPV4 FLUN
Days 1
State TX
Manufacturer MERCK & CO. INC. MEDIMMUNE, INC.
Prev Doses 1
ER VISIT, NOT SERIOUS Facial palsy
Symptom Text: Information has been received from a physician concerning an 11 year old female who was the daughter of a nurse that works in his office. On 30-SEP-2006 the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot #654540/0800F). At that same time, the patient received a second dose of FLUMIST. On 01OCT-2006 the patient had a "funny feeling in her face." By 03-OCT-2006 "her face was crooked on one side and becoming paralyzed." The patient was treated with an unspecified steroid medication and was reported to be "feeling better," but the symptoms were not totally gone. The patient was seen by a neurologist and was diagnosed with Bell's Palsy. The physician reported that one year ago, the patient was given FLUMIST and had no adverse reactions. At the time of this report, the patient was recovering from the events. The physician reported that it was his opinion that "Bells Palsy was caused by FLUMIST and not GARDASIL." Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 241
Days 0
State DE
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a 21 year old female with a history of an allergic reaction to penicillin and sulfonamide who on 21-SEP2006 was vaccinated with HPV. On 21-SEP-2006, following vaccination, the patient broke out in hives all over her upper body particularly in the face, chest, and arms. Unspecified medical attention was sought. Subsequently, the patient recovered on 26- SEP-2006. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Hypersensitivity reaction Penicillin allergy; Sulfonamide allergy


Page 242
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Fatigue, Hypoaesthesia, Injection site erythema, Injection site mass, Malaise, Pruritus, Pyrexia, Thermal burn
Symptom Text: Information has been received from a physician and a 22 year old white female certified medical assistant with latex allergy, drug hypersensitivity to pertussis and iodine allergy and a history of unspecified adverse reaction after first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (at less than 1 year of age. On 05-OCT-2006, at 4:00 PM,. the patient was vaccinated, into the right arm, with a first dose of HPV (lot # 653978/0955F). On 05-OCT2006, at 4:00 PM, the patient experienced burning "as if the arm was cut with razor blade and alcohol was poured on cut," and it "hurt really bad." The patient also developed dizziness, numbness in her lower arm, fever, fatigue, and malaise. She reported that her arm swelled up 2 times the normal size and was red. She developed a dime size lump and redness at the injection site that was itchy when touched or pressed on. Unspecified medical attention was sought. At the time of the report, the dime size lump, redness and itching at the injection site persisted. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Vaccination adverse reaction Latex allergy; Drug hypersensitivity; Iodine allergy


Page 243
Days 1
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Abdominal pain, Dysuria, Vaginal pain
Symptom Text: Information has been received from a certified medical assistant concerning a 16 year old female who on 05-OCT-2006 was vaccinated with a first dose of HPV (lot # 653735/0688F). There was no concomitant medication. on 06-OCT-2006 the patient experienced sharp pain around the abdomen area and vaginal area and intense pain during urination. It was reported that the pain was on and off. It was reported that the patient was going to go to the physician's office to be evaluated. At the time of the report, the patient's outcome was unknown. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 244
Days 0
State CA
Prev Doses
Symptom Text: Information has been received from a registered nurse concerning a 12 year old female with no past medical history who on approximately 10/4/06 was vaccinated, into the arm, with a 0.5ml dose of HPV vaccine. Concomitant therapy included a dose of Hep A vaccine. It was reported that the nurse rubbed the childs arm after the vaccination and the child passed out. The physician thought that it was a vasovagal reaction and revived her with ammonia. On approximately 10/04/06, the pt recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 245
Days 0
Received Date 16-Nov-2006 Lot NULL NULL NULL
State CA
Mfr Report Id WAES0610USA09277 Route Unknown Unknown Unknown
Type VARCEL HPV4 FLU
Manufacturer MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER
Prev Doses
ER VISIT, NOT SERIOUS Hypoaesthesia, Injection site reaction
Symptom Text: Information has been received from a physician concerning a 12 year old female with asthma and Advair allergy who on 10/11/06 was vaccinated with HVP vaccine. Concomitant therapy that day included varicella virus vaccine and influenza vaccine. On 10/11/06 the pt experienced numbing at injection site and around arm. The pt recovered. Unspecified medical attention was sought. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Asthma, drug Hypersensitivity.


Page 246
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Flushing
Symptom Text: Information has been received from a nurse concerning her 15 year old niece who was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast) (0.5 ml). Subsequently, "soon after having injections", the patient experienced dizziness and flushing "about ten minutes after her injections". It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) with "other shots" and blood work. The patient recovered ;about 15 minutes after injections". Unspecified medical attention was sought. Additional information has been requested. (therapy unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 247
Days 1
State MA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 22 year old female who on 11-Oct-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653978/0955F) (0.5ml), intramuscularly. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 12-Oct-2006 the patient experienced "rash on her face and neck". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. ORTHO TRI-CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 248
Days 1
State CA
Prev Doses
NO CONDITIONS, NOT SERIOUS Muscle spasms, Myalgia
Symptom Text: Information has been received from a physician concerning a 14 year old female student who on 05-Oct-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653735/0688F). Concomitant therapy given at the same time in the same arm included a dose of hepatitis A virus vaccine (unspecified). On 06-Oct-2006, the patient experienced extremely severe cramping pain in arm at the vaccine site intermittently over about 16 hours following vaccination. The episodes lasted about 30 minutes each and were incapacitating. During the time between episodes the patient was completely pain free. The episodes continued through the night with the same intensity. The episodes stopped abruptly the next morning and there was no reoccurrence. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 249
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness at the injection site and numbness around the arm. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 250
Days 7
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site mass, Injection site warmth
Symptom Text: Information has been received from a health professional concerning a 22 year old female with hypertension and "an interstitial problem" NOS who on 09-Oct2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Concomitant therapy included unspecified therapy. On 16-Oct-2006 the patient developed a "quarter size knot at the injection site that was warm to touch". Medical attention was sought and the patient was treated with diphenhydramine hydrochloride (BENADRYL). It was reported that the patient will discontinue the vaccination series. At the time of this report the patient had not recovered from the event. Additional information has been requested. (therapy unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CONCURRENT CONDITIONS: Hypertension; General symptom


Page 251
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). The physician reported that the patient "was administered the shot and then fainted/passed out". Unspecified medical attention was sought. The physician reported that the patient recovered from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 252
Onset Date Unknown
Days
State VA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, following the vaccination, the patient fainted. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 253
Days 0
State OK
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Erythema
Symptom Text: Information has been received from an office manager and a 42 year old female medical assistant with a Penicillin allergy who on 18-Oct-2006 went to place the needle on the HPV rL1 6 11 16 18 VLP vaccine (yeast0 (Lot#653650/0640F) pre-filled syringe and the medication squirted "out of the syringe" into the air. Concomitant therapy included bupropion HCl (WELLBUTRIN SR), Clarithromycin (BIAXIN), acetaminophen/hydrocodone bitartrate (LORTAB) and Trazodone HCl. The medication did get on her hands and she was experiencing burning and had redness on her index finger. It was warm to touch. At the time of this report, the patient was recovering from the events and the redness was decreasing. Additional information has been requested. LORTAB, WELLBUTRIN SR, BIAXIN, trazodone hydrochloride Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK CONCURRENT CONDITIONS: Penicillin allergy


Page 254
Days 1
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Rash, Urticaria
Symptom Text: Initial and follow up information has been received from a physician concerning a 17 year old white female student with no pre-existing medical conditions. On 10-Oct2006, at 4 PM, the patient was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Concomitant therapy included an unspecified therapy (reported as "over-the-counter acne medication'). There were no illnesses noted at the time of vaccination. The physician reported that when the patient left the office she was fine. That same day, the patient had been given desloratadine (CLARINEX) without positive result, by her mother and without physician consultation. On 11-Oct-2006, at 4 PM, the patient developed a rash which appeared on the ear tips, face, elbows, knee caps and around the belly button area. On 14-Oct-2006, the patient went to the emergency room (ER) but was not admitted for an overnight stay. The patient was treated with prednisone. The physician reported that she did not see the patient. The physician reported that the patient "had hives" and was given the steroids in the emergency room which she considered to be routine. At the time of this report, the patient had not recovered from the event. The physician considered the event to be non-serious. Additional information is expected. (therapy unspecified), CLARINEX Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 255
Days 0
State TX
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Loss of consciousness, Muscle contractions involuntary
Symptom Text: Information has been received from a 23 year old female who on 03-OCT-2006 was vaccinated with a 0.5 mL dose of GARDASIL. The patient reported that the vaccine was given in the front part of the thigh muscle. Subsequently, the muscle contracted and the patient passed out due to pain. Unspecified medical attention was sought. When the patient woke up, she reported that she "felt fine." On 03-OCT-2006, the patient recovered from the events. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 256
Days 0
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from an LPN concerning a 30 year old female patient with anxiety who on 11-Sep-2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot#654540/0800F. Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). After receiving the vaccination on 11-Sep-2006, the patient complained of a lot of pain under the arm pit and also on the left arm (injection arm). The arm hurt on and off, especially during workouts and while sleeping. the pain wakes up the patient in the middle of the night. She sought medical attention and was told to take Ibuprofen, apply ice to the area, and no upper body exercises. The nurse stated the patient was still having moderate pain 4 weeks after the injection, and that she probably would not receive further doses. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. LO/OVRAL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE CONCURRENT CONDITIONS: Anxiety


Page 257
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Upper respiratory tract infection
Symptom Text: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with a 0.5 ml dose of HPV vaccine. Subsequently the pt developed an upper respiratory infection. The pt sought unspecified medical attention. The nurse practitioner stated that she told the pt when the pt called the office that she did not feel the upper respiratory infection was caused by the HPV vaccine. No further information was provided at the time of this report. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 258
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Condition aggravated, Diarrhoea, Irritable bowel syndrome, Loss of consciousness, Nausea, Pain, Vomiting
Symptom Text: Information has been received from the mother of a 24 year old female with irritable bowel syndrome and food allergies to 28 different foods, including yeast and corn who on 10/16/06 was vaccinated with HPV Vaccine. Concomitant therapy included Hormonal contraceptives (unspecified) and dermotologic (unspecified). On 10/16/06 the pt experienced nausea, diarrhea, aches, and vomiting which continued for three days without changes. On 10/19/06, it was reported that the pts irritable bowel syndrome was also triggered by the above events. On 10/19/06 the pt underwent a blood test (usually very well tolerated), however following the blood test on 10/19/06, the pt passed out and vomited, Unspecified medical attention was sought. The pts mother stated that she would be contacting her daughters physician with the listed allergies. At the time of this report, the pt was recovering from the events. Additional information is not expected. Dermotologic Unsp, Hormonal contraceptives. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Diagnostic lab 10/19/06 Food allergy, Irritable bowel syndrome.


Page 259
Onset Date Unknown
Days
State CT
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Influenza like illness, Malaise
Symptom Text: Information has been received from a nurse concerning a female pt who on an unspecified date was vaccinated IM with HPV vaccine (it was reported that it was uncertain whether this was the pts first dose). Subsequently, the day after vaccination, the pt experienced flu-like symptoms, felt horrible and felt very sick for a few days. At the time of this report, the pt had no more flu-like symptoms. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 260
Days 0
State FR
Prev Doses
Site Unknown
Symptom Text: Information has been received from a 38 year old female pt who on 8/22/06 was vaccainted IM with a dose of HPV vaccine. The reporter stated that on 8/22/06 I had pain for two months after the injection. Medical attention was sought. The pt was recovering. A product quality complaint was not involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 261
Onset Date Unknown
Days
State CO
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Lymphadenopathy, Swelling
Symptom Text: Information has been received from a physician concerning a 21 year old female who in approximately September 2006 was vaccinated with the first dose of GARDASIL (lot # not provided). On an unspecified date in approximately September the patient developed swelling in her lymph nodes and groin. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 262
Days 9
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 27 year old female who on 10/3/06 was vaccinated with the first dose of HPV Vaccine (lot nor provided). On 10/12/06 the pt experienced a very sore arm. The physician advised the pt to take Advil and apply ice to the area. At the time of the report it was unk if the pt had recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 263
Onset Date Unknown
Days
State MO
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 15 year old female who was vaccainted with the first dose of HPV vaccine (lot # not provided). Subsequently the pt experienced low grade fever. The physician reported that the pt received Tylenol and felt better. Subsequently, the pt recovered from the low grade fever. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 264
Days 1
State MO
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Nausea, Pyrexia
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 10/16/06 was vaccinated with an IM HVP vaccine (lot 653978/0955F). On 10/17/06 the pt was sent home from school because she developed a fever of 102F and nausea. the physician reported that after 12 hours the pt recovered and returned to school the next day symptoms free. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 265
Onset Date Unknown
Days
State CT
Mfr Report Id WAES 0610USA12537 Route Unknown
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Nausea
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 266
Vaers Id: 267454-1 Age Gender F Unknown VAX Detail: Type HPV4 HEP DTOX Seriousness: MedDRA PT
Days 1
State IA
Manufacturer MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER
Lot Prev Doses 653650/0702F NULL NULL
ER VISIT, NOT SERIOUS Pruritus
Symptom Text: Information has been received from a physician concerning a female in her 20's with intermittent problems with asthma and no known drug allergies, who on 22-SEPT-2006 was vaccinated into the left deltoid with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). (Lot #653650/0702F). Concomitant therapy given that day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of hepatitis A virus vaccine inactivated (+) hepatitis B virus vaccine rHBsAg (yeast) (Twinrix). It was noted that the vaccines were administered at different anatomical sites. Within 24 hours, the patient experienced intense itching all over her body. Unspecified medical attention was sought. The patient self medicated with diphenhydramine hydrochloride(Benadryl). No diagnostic laboratory tests were performed. One week later, the patient fully recovered. No product quality complaint was involved. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 267
Days 1
State FM
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 12 year old white female with no know drug allergies, who on 28-SEP-2006 at 14:30 was vaccinated IM into the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). (Lot #653978/0955F). On 29-SEP-2006 at 08:00 the patient experienced a "large red rash area near the injection site, 1x1cm red around injection site and 3x2cm spot in the superior lateral site area, and red raised spot inferior and lateral to the injection site." No diagnostic laboratory studies were performed. The patient was treated with cool compresses, ibuprofen (Advil) or ibuprofen (Motrin) and cetirizine hydorchloride (Zyrtec) every 6 to 8 hours. The patient was told to go to the emergency room if her condition worsened. Subsequently, the patient recovered as there was no more follow up phone calls to the office. Additional information is not expected. Unknown Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 268
Days 0
State OH
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient developed severe arm pain at the injection site. At the time of this report, the outcome of the event was unknown. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 269
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Swelling
Symptom Text: Information has been received from a midwife registered nurse concerning a female with genital warts who "within the last few weeks" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included imiquimod (Aldara). Subsequently "within the last few weeks" the patient experienced "swelling in genital warts". At the time of the report the patient was recovering. Unspecified medical attention was sought. Other information has been requested. Aldara Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 270
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Medication error, Post vaccination syndrome
Symptom Text: Information has been received from a registered nurse concerning a female who on 24 Oct 2006 was vaccinated with Gardisil (Lot #654540/0800F). The nurse reported that on 24 Oct 2006 the pre-filled syringe while she was withdrawing the syringe and the patient received an incomplete dose of the vaccine. She thought most of the dose was administered. The patient also stated that "the vaccination hurt." Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 271
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Lymphadenopathy, Pelvic pain
Symptom Text: Information has been received from a triage nurse concerning a female (age unknown) with no other pertinent medical history reported. On approximately 17 Oct 2006, the patient was vaccinated with a 0.5mL dose of Gardisal. There were no concomitant medications reported. On an unspecified date, the patient contacted the nurse complaining about pain and swelling of the lymph nodes, in the groin area on her right side. Unspecified medical attention was sought. At the time of this report, the outcome of the events were unknown. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 272
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Influenza like illness, Malaise, Myositis
Symptom Text: Information has been received from a physician concerning a female who was vaccinated IM with a 0.5ml first dose of Gardisal. Approximately 3 to 4 days after the vaccination, the patient experienced "myacitis", malaise and flu like symptoms and went to the emergency room. Subsequently, the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 273
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a health professional concerning a 17 year old female with no medical history or allergies, who on 20 Aug 2006 and 20 Oct 2006 was vaccinated IM with a first and second 0.5mL dose of Gardisal, respectively (first dose lot # 654540/0800F and second dose lot # 653736/0868F). There was no concomitant medication. On 20 Aug 2006, the patient experienced nausea and emesis. On 20 Oct 2006, the patient again experienced immediate nausea and vomiting. On 21 Oct 2006 the patient experienced low grade fever. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered from emesis. At the time of this report, the patient's low grade fever persisted and the outcome of nausea was unknown. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 274
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a Registered Nurse concerning an adult patient who was vaccinated with a dose of Gardisal. The patient complained of pain while being injected using the prefilled syringe. The nurse reported that another patient did not complain of pain when a "normal" syringe was used. The nurse suggested the pre-filled needles may be dull causing pain during injection. The patient's out come was not reported. A product quality complaint was involved. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 275
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Syncope vasovagal
Symptom Text: Information has been received from a nurse practitioner concerning a female who was vaccinated intramuscularly with a dose of Gardisil. The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 276
Days 10
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site induration, Injection site pain
Symptom Text: Information has been received from a physician concerning a 12 year old female who on 11 Oct 2006 was vaccinated with the first dose of 0.5mL of Gardisil (Lot # 653937/0637F). On 21 Oct 2006, the patient developed a know on the arm with no rash and no redness. On 24 Oct 2006, the patient developed throbbing pain around the arm that the injection was administered. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 277
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who on 28 Aug 2006 was vaccinated with a first dose of Gardisil. On 28 Aug 2006 the patient experienced vomiting within four hours of receiving the vaccination. Outcome was not reported. On 25 Oct 2006, the patient was vaccinated with a second dose of Gardisil. On 25 Oct 2006 the patient experienced vomiting within four hours of receiving the vaccination. On 25 Oct 2006, the patient recovered from vomiting. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 278
Days 25
State AL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Chills, Headache, Herpes simplex, Insomnia, Pain, Pyrexia, Rhinorrhoea
Symptom Text: Information has been received from a Certified Medical Assistant concerning a 21 year old female patient with a history of bacterial vaginosis and yeast infections who on 28 Aug 2006 was vaccinated IM in left deltoid with her first dose of Gardisil vaccine (yeast) lot #653736/0689F. Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen). ON 22 Sep 2006 the patient developed fever, which she reported was "off and on". She described the fever as spiking at night after 6-7pm. Her fevers would reach 101-103 F and they resolved with rest plus the use of acetaminophen (Tylenol). After " a couple days or so", the fevers would reappear. Other symptoms included headache, hot and cold chill, body aches, waking in the night. The CMA stated that the patient reported these symptoms to the physician's office on 23 Oct 2006. Laboratory tests performed on that date included HSV(herpes simplex virus) IGG type 1 (positive); HSV IGG type 2 (negative); and EBV(Epstein-Barr virus) (negative). It was reported "EBN was positive". Also reported was "sed rate and CBC=white blood cell count was normal". The patient was to be seen the following week to determine whether the fevers continued. Follow up information indicated that when the patient was seen on 30 Oct 2006 she received a second dose of Gardisil. The CMA noted that the patient was fine "so far". Additional information has been requested. Ortho Tri Cyclen Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: body temp 101-103F; clinical seriology test, 10/23/06, positive; serum Epstein Barr 10/23/2006 negative, serum herpes simplex 10/23/06 positive; serum herpes simplex negative; WBC count normal Medical History: Vaginosis bacterial, yeast infection


Page 279
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Blister, Oral mucosal blistering, Swelling
Symptom Text: Information has been received from a physician concerning a female patient who on 26-OCT-2006 was vaccinated IM with a first dose of GARDASIL. On 26OCT-2006 the patient experienced swelling as well as blisters in mouth and on the neck. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 280
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female teenager who was vaccinated IM with a first dose of Gardisil. The patient "passed out" when she received the injection. The physician is planning to give the doses as recommended. Unspecified medical attention was sought. Shortly after vaccination, the patient recovered. No product quality complaint was involved. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 281
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pain, Pain, Pyrexia
Symptom Text: Information has been received from a physician concerning an 18 year old female who on 23 Oct 2006 was vaccinated with 0.5mL of Gardisil (yeast). There were no concomitant medications reported. On 23 Oct 2006, the patient developed a high fever of 102 degrees after receiving shot of Gardisil. The temperature continued for three days and was now noted at 100 degrees. The patient also developed achy legs. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: body temp 10/23/06 102, body temp 10/26/06 100. UNK


Page 282
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Amenorrhoea, Incorrect dose administered
Symptom Text: Information has been received from a physician assistant in her "late thirties" who on an unspecified date was vaccinated intramuscularly with the first dose of Gardisil vaccine (yeast). The physician assistant reported that she did not get her period the first month after the Gardisil vaccine. It was unknown if the patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as " the patient was not due yet for her next menstrual cycle". Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 283
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of Gardisil vaccine (yeast). The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 284
Days 2
State MN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Pyrexia
Symptom Text: Information has been received from a physician concerning a "15 or 16 year old" female who on approximately 25 Oct 2006 or 26 Oct 2006 was vaccinated intramuscularly in the deltoid with Gardisil. On approximately 27 Oct 2006, the patient developed a low grade fever of about 99 and dizziness. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: body temp 10/27/06 -about 99 Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 285
Days 0
State IL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Vaccination complication
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 31-OCT-2006, the patient was vaccinated intramuscularly with GARDASIL. There were no concomitant medications reported. Subsequently, the patient experienced a cut which was less than 1/4 inch when the syringe was pulled out from the patient. It was reported that the patient had received the full dose. The patient sought unspecified medical attention. The registered nurse reported that the cut was very minor. At the time of this report, the patient was recovering from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 286
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Dyspnoea, Tension, Throat tightness
Symptom Text: Information has been received from a physician concerning a female age "14 or 15 years old" who on an unspecified date was vaccinated with the first dose of 0.5 ml of GARDASIL. After vaccination, the patient felt faint. It was reported that the patient felt dizzy, had difficulty breathing (also reported as "had a short of breath feeling"), felt like her throat was closing and looked tense. Her lungs were clear, there was no wheezing, no signs or symptoms of swelling, no facial or eye swelling and her blood pressure was stable. The physician reported that she thought this looked like a "slight reaction." The patient was given diphenhydramine hydrochloride (BENADRYL) as a precaution. The physician reported that the events were resolving that same day. It was reported that the patient "experienced similar symptoms not relating to vaccines and felt the symptoms may have been more panic driven than anything else." At the time of this report, the patient had recovered from the events (date unknown). The physician reported that she did not feel that the treatment with diphenhydramine hydrochloride (BENADRYL) was needed to prevent serious criteria and did not feel that this experience was life-threatening to the patient. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Adverse event


Page 287
Days 1
State NY
Type HPV4 HEPAB
Manufacturer MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS
Prev Doses 0 2
ER VISIT, NOT SERIOUS Vision blurred
Symptom Text: Initial and follow-up information has been received from a physician concerning a 26 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 24-OCT-2006 the patient was vaccinated intramuscularly in the deltoid with the first "1 vial" dose of GARDASIL (lot #653938/0954F). Concomitant therapy included azithromycin (ZITHROMAX). It was reported that on 24-OCT-2006, the patient had been vaccinated with the third dose of TWINRIX. On 25-OCT-2006, "within a day after immunization," the patient experienced blurry vision in both eyes. The patient sought unspecified medical attention. The patient was told by the physician to come to the office to be evaluated but had not. As of 02-NOV-2006, nine days after receiving GARDASIL, the physician reported that the blurred vision was "getting much better." Additional information has been requested. ZITHROMAX Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 288
Days 0
State OH
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Vomiting
Symptom Text: Information has been received from a registered nurse concerning a 13 year old female who on 30-OCT-2006 was vaccinated with GARDASIL. Subsequently, the patient experienced redness in her face and had vomited. The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 289
Days 0
State IN
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning an 18 year old female patient who on 30-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653978/0955F. Immediately after receiving the vaccination the patient fainted. She was sent to the emergency room, where it was determined she had fainted "due to nervousness over the needle." The patient recovered "a few hours" after the vaccination. There was no product quality complaint involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 290
Days 0
State NC
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 21 year old female who on 30 Oct 2006 was vaccinated with 0.5mL of Gardisil (Lot# 653736/0689F). On 30 Oct 2006, the patient developed a vasovagal reaction and passed out within one minute post vaccination. The patient was revived with an ammonia inhalant. No other symptoms were noted. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 291
Days 0
State NC
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fall, Loss of consciousness, Loss of consciousness
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female with no pre existing allergies, birth defects or medical conditions and reportedly was not ill at the time of vaccination. On 10/30/06, when the pt checked into the physicians office her blood pressure was 80/50. On 10/30/06, at 12:30pm, the pt was vaccinated IM into the left deltoid muscle with HPV vaccine (lot # 653736/0689F). Concomitant therapy included Ortho Tri Cyclen Lo), Claritin and Celexa. After the pt received the vaccination, she passed out and was unconscious, she hit her head when she fell forward out of her chair. The pt had a neurological check up per in internal medical physician. The pt was checked by two physicians and they considered the pt had a vasovagal reaction. The pt left the office ambulatory, alert, recovered and in satisfactory condition. Additional information has been requested. Celexa, Ortho Tri Cyclen Lo, Claritin Other Meds: Blood pressure 10/30/06 80/50 Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 292
Days 0
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a certified medical assistant and a physician concerning a 25 year old female with a history of hives due to orange juice who in approximately Oct 2006, a couple of weeks ago, was vaccainted with a 0.5ml first dose of HPV vaccine (lot 653736/0689F). There was no concomitant medication. Approximately 30 minutes after the vaccination, the pt experienced severe itching all over her body. It was reported that there was no rash. Unspecified medical attention was sought. Subsequently, the pt recovered after approximately 2 days. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Hives, food allergies.


Page 293
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Viral infection
Symptom Text: Information has been received from a licensed practical nurse concerning a 15 year old female with migraines and no known allergies or adverse drug reactions reported. On approx 8/31/06, the pt was vaccinated with the first dose of HPV vaccine. On an unspecified date, the pt was noted to be positive for an unknown number of high risk human papilloma virus types. The pt underwent a pap test (date and results not reported). The pt sought unspecified medical attention. a colposcopy was planned for the pt. At the time of this report, the pt had not recovered from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pap Test UNK


Page 294
Days 0
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Asthenia, Dizziness, Hyperhidrosis, Pallor
Symptom Text: Information has been received from a nurse practitioner concerning a female pt who in Oct 2006, was vaccinated IM with a dose of HPV Vaccine. Subsequently in Oct 2006, she experienced lightheadedness, weakness, pallor, and sweating, No medical attention was sought. The nurse practitioner indicated the pt was doing fine. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 295
Days 0
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Asthenia, Dizziness, Hyperhidrosis, Pallor
Symptom Text: Information has been received from a nurse practitioner concerning a female pt who in Oct 2006, was vaccinated IM with a dose of HVP vaccine. Subsequently in Oct 2006 she experienced lightheadedness, weakness, pallor and sweating. No medical attention was sought. The nurse practitioner indicated the pt was doing fine. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 296
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Ocular hyperaemia, Pruritus, Rash
Symptom Text: Information has been received from a nurse concerning an 18 year old female who on 30-OCT-2006 was vaccinated with the first dose of GARDASIL. On 30OCT-2006 the patient developed a "rash on the palm of her hand and also red, itchy eyes." The patient sought unspecified medical attention. The nurse reported that the patient had recently purchased new eye makeup. At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 297
Days 0
State OH
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Vomiting
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on 10/30/06 was vaccainted with HPV vaccine. Subsequently, the pt experienced redness in her face and had vomited. The pt sought unspecified medical attention. At the time of this report, the pt was recovering from the event. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 298
Onset Date Unknown
Days
State CT
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced dizziness and nausea within a few minutes post-vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 299
Onset Date Unknown
Days
State CT
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently, the patient experienced dizziness and nausea within a few minutes post-vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 300
Onset Date Unknown
Days
State CT
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 301
Onset Date Unknown
Days
State CT
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female pt who on an unspecified date was vaccainted with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 302
Onset Date Unknown
Days
State VA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following the vaccination, the pt fainted. At the time of this report, the outcome of the event was unk. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 303
Onset Date Unknown
Days
State VA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following the vaccination, the pt fainted. At the time of this report, the outcome of the event was unk. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 304
Days 0
State PA
Prev Doses 0
Symptom Text: Total body itching Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Von Willebrands, MRSA Coumadin


Page 305
Days 0
State PA
Prev Doses 0
Symptom Text: Total body itching. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seasonal Allergies Allegra D


Page 306
Days 0
State CA
Prev Doses 1
Site Unknown
ER VISIT, OMIC, SERIOUS Condition aggravated, Convulsion, Fall, Syncope
Symptom Text: Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of a prior seizure (on an unk date about a year ago during a hair cut) who on 11/6/06 was vaccinated IM in the deltoid with the second dose of HPV vaccine (lot not provided). It was reported that the pt had no difficulties when the first dose of the vaccine was administered on an unspecified date. On 11/6/06 the medical assistant administered the vaccine, then turned to discard the needle. The pt fainted, fell from the exam table, hit her head on the floor and had a seizure. Paramedics were called, a cervical collar was placed on the pt and she was transported to the ER. The pt was evaluated in the ER, a CT scan was performed which was reported as normal. The pt was discharged to home from the ER and instructed to follow up with neurology. The medical assistant stated that the physician felt that the pt had a vasovagal response after receiving the vaccine and that the seizure was a result of the head trauma which the pt suffered from the fall off the exam table. It was reported that the physician felt that the seizure was related to the head trauma and not related to the vaccine. The medical assistant also reported that the physician felt the pt had recovered from the event. Upon internal medical review the seizure was felt to be an important medical event (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Convulsion


Page 307
Days 0
State AL
Prev Doses 0
Site Right arm
Symptom Text: Overall fine body rash for past 2 days. Pt has a concomitant tonsillitis onset 2 days ago - negative strep Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKDA Dyspnea; Tonsillitis Effexor XR


Page 308
Related reports: 267795-2 Vaccine Date Onset Date 09-Nov-2006 09-Nov-2006 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Days 0
Received Date 27-Nov-2006 Lot U2119AA 0688F
State CA
Mfr Report Id 200603096 Route Unknown Unknown
Prev Doses
Site Gluteous maxima Right arm
ER VISIT, OMIC, SERIOUS Agitation, Anger, Crying, Depression, Pain, Suicide attempt
Symptom Text: Seriousness criteria other medically significant (OMIC). Initial report received from the pts mother via a health care professional, on 11/14/06. A 14 year old female pt, received on 11/9/06, Menactra (lot number U2119AA), into the right deltoid (dose and route of administration not reported). The pt received on the same day (11/9/06) Gardasil (lot number 0688F) into the left deltoid, as concomitant vaccination (dose and route of administration not reported). The pt had no history of depression. At the eve of vaccination, 11/9/06, the pt had arm soreness (the reporter was unsure which arm). The pt also became very depressed, frustrated, angered, crying and attempted to cut her wrists with scissors. The wrist site described as scratch by the reporter. At the time of this report, 11/14/06, there had been no ER or medical doctor MD visits for the pt and the pts outcome was unk. No corrective treatment was reported. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 309
Related reports: 267795-1 Vaccine Date Onset Date 09-Nov-2006 09-Nov-2006 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Days 0
State CA
Prev Doses
OMIC, SERIOUS Agitation, Crying, Crying, Depression, Depression suicidal, Injury, Suicide attempt
Symptom Text: Information has been received from a physician concerning a 14 year old female with no history of depression or suicidal ideation who on 09-NOV-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) concomitantly with a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). Later that day, the pt became depressed. The pts mother reported that the pt became weepy and crying and stated I wish I were dead. On 10-NOV-2006, the pt stated that she wished she were dead and later made some superficial cuts on her arm. The physician reported that she was informed of the event 4 days later it occurred and saw the pt 6 days post vaccination. At that time, the pts physical examination was normal and there were no injection site reactions. The pt was not hospitalized and did not receive treatment for the event. The physician considered the pt recovered from the event. The physician considered the pts suicide attempt and depression were considered to be other important medical events (OMIC). UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 310
Days 1
State IL
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Erythema, Malaise, Pruritus, Swelling face, Throat tightness
Symptom Text: Pt suddenly did not feel well at 9:30 am 11/15 went to bathroom, noticed face very red, followed by intense itching - presented to clinic 1 hr after sxs started, developed swollen lips, edema around eyes and throat constriction. Epi 0.05 ml SQ immediately. 3 min later, pt improved. Benzaclin, Minocin, Orthotricyclen, Prozac Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Acne, Anxiety, depression, TSS (11/05) NONE


Page 311
Days 0
State CA
Prev Doses 0
Symptom Text: Patient fainted after administration of vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 312
Days 14
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Abdominal pain, Hypoaesthesia, Injection site pain, Pain
Symptom Text: Left arm pain, numbness from elbow to entire hand, started about 2 week safer receiving Gardasil in that arm. Pain is intermittent and 5-10 in intensity. She dose have other symptoms of abdominal pain, and right arm pain, so it is unclear whether vaccine is a factor. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Mild Pulmonary Valve stenosis, stable. NONE


Page 313
Days 4
State MO
Prev Doses
NO CONDITIONS, NOT SERIOUS Oedema peripheral, Swelling face
Symptom Text: 2nd dose Patient medicine on 11-20-06 and complain of swelling in lips, hands, and feet. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 314
Vaers Id: 267996-1 Age Gender U 14.0 VAX Detail: Type HPV4
Onset Date Unknown
Days
State MO
Prev Doses
Symptom Text: 2nd dose Patient complain of pain. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 315
Vaers Id: 267997-1 (S) Related reports: 267997-2 Age Gender Vaccine Date Onset Date F 22-Sep-2006 23-Sep-2006 15.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 1
State NJ
Prev Doses 0
HOSPITALIZED, SERIOUS Confusional state, Disorientation, Dysmorphism, Grand mal convulsion, Hypoglycaemia, Mental status changes
Symptom Text: Patient awoke morning after vaccination with grand mal seizure. Her mother took her to a local hospital and she was transferred to another hospital and then to another. MR received from 1st ER visit which reveals a 15 yr old brought in by her mother with c/o confusion, disorientation, and facial distortion on the morning following her Gardasil vax. PE: Significant for confusion and disorientation, otherwise normal. Patient was transfered to another hospital to be followed by a pediatric neurologist, Clinical impression : Altered mental status. MR received from 2nd hospital. Pt. transfered to PICU with a diagnosis of altered mental status. Still somewhat confused but improving upon admission. Improvement in mental status over the next 24 hours and she was transfered to a regular pediatric floor, oriented x3 and with no focal deficits. Discharge DX: New onset seizures (probably 2' to hypoglycemia per face sheet). Insulin Meds: Lantus insulin and Novolog. Other Meds: Labs and Diagnostics: EKG shows sinus arythmia, Drug and pregnancy screens (-), other labs WNL including serum glucose, CXR-normal, head CT-(-). Labs Lab Data: and Diagnostics: UA significant for >1000mg/dl glucose and 40 ketones. HgbA1C 8.8, oth Type 1 Diabetes. NKDA History: Prex Illness: Prex Vax Illns:


Page 316
Vaers Id: 267997-2 (S) Related reports: 267997-1 Age Gender Vaccine Date Onset Date F 22-Sep-2006 23-Sep-2006 15.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 1
State NJ
Prev Doses 0
Site Unknown
EXTENDED HOSPITAL STAY, HOSPITALIZED, OMIC, SERIOUS Grand mal convulsion
Symptom Text: Information has been received from a physician concerning a 15 year old female with type 1 diabetes mellitus who on 9/22/2006 was vaccinated by injection with her first dose of HPV vaccine (lot 654540/0800F). Concomitant therapy included insulin. On 9/23/06, the day after receiving the HPV vaccine, the pt experienced a Grand mal seizure. the physician reported the pt was hospitalized for 3 days. The pt had the following lab diagnostic studied. spinal tap, MRI, EEG, blood work and urine. The physician stated the pt returned to the office to received the second dose of HPV vaccine, but the physician decided not to reintroduce the HPV vaccine. At the time of the report, the pt had recovered. The physician considered the pts Grand Mal Seizure to be an other important medical event (OMIC). Additional information has been requested. Insulin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Type I Diabetes Mellitus.


Page 317
Onset Date Unknown
Days
State TN
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dyskinesia
Symptom Text: Patient developed jerking in upper extremity a few hours after administration of vaccine. Patient was medicated with VALIUM which led to resolution of symptoms. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 318
Vaers Id: 268036-1 (S) Related reports: 268036-2; 268036-3 Age Gender Vaccine Date Onset Date Days F 28-Nov-2006 28-Nov-2006 0 20.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
State IA
Prev Doses 0
ER VISIT, HOSPITALIZED, SERIOUS Abdominal pain, Abdominal pain lower, Gastrointestinal disorder, Vomiting
Symptom Text: Less than 3 hours following the vaccination she developed severe abdominal cramps and vomited. Subsequently had persistent abdominal pain that eventually localized to the right lower quadrant. A CT of the abdomen was performed the evening of 11/29/06 which revealed appendicitis. A surgical consultation was requested and days of hospitalization are unknown yet at this time. Student health office note of 11/28/06 recording administration of Gardasil #1 on this date. Hospital record received revealing a 20 year old woman who developed crampy abdominal pain centered in the right lower quadrant 1 day following her Gardasil vax. Patient had appendectomy and was dischaged home the following day. DX: Appendicitis. Ortho Tri-Cyclen Lo Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Labs and Diagnoatics: WBC's 11.0, Abdominal CT shows a thickened appendix at the base of the cecum with surrounding inflammation c/w acute appendicitis. PMH: none Allergies: none none


Page 319
Related reports: 268036-1; 268036-3 Vaccine Date Onset Date Days 28-Nov-2006 28-Nov-2006 0 Manufacturer MERCK & CO. INC.
Status Date 08-Jan-2007
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Abdominal pain, Insomnia
Symptom Text: Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She is being referred to a specialist to rule out appendicitis. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: abdominal ultrasound, 11/29?/2006, computer axial, 11/29?/2006 UNK


Page 320
Received Date 20-Dec-2006 Lot NULL
State IA
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Abdominal pain, Vomiting
Symptom Text: Shot was given on Nov 28th Tues within 2 hours pt vomiting and abd pain. then worsened to not being able to lay supine. Wed Nov 29th tried to wait SX out but went to student health where Dr asked her to go to hospital for CBC and ABD CT scan. As 0.02% appendicitis from Gardasil. She then proceeded to have appendectomy. Ortho Tricycline LO Other Meds: Increase CBC and ABD CT abnormal. APPY. Lab Data: History: Prex Illness: Prex Vax Illns:


Page 321
Vaers Id: 268143-1 (S) Related reports: 268143-2; 268143-3; 268143-4 Age Gender Vaccine Date Onset Date Days Received Date F 22-Nov-2006 30-Nov-2006 8 13.0 03-Dec-2006 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC. Lot NULL
State AK
Last Edit Date 22-Feb-2007 Other Vaccine PPV
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Autonomic nervous system imbalance, Autonomic nervous system imbalance, Back pain, Extubation, Fall, Gait disturbance, Guillain-Barre syndrome, Hypertension, Hypoaesthesia, Hypoaesthesia, Hyporeflexia, Intubation, Muscular weakness, Muscular weakness, Neuralgia, Pneumonia haemophilus, Respiratory failure, Staphylococcal infection, Tachycardia, Tracheostomy, Upper respiratory tract infection, Urinary retention, Vital capacity decreased
Symptom Text: Pt admitted to hospital on 12/1/06 with chief complaint of ascending weakness bilaterally, upper and lower extremities. Neuro consult diagnosed Guillain-Barre syndrome. Pt received the Gardasil vaccine on 11/22/06. Resident MD asked pharmacist to write up possible ADR of Guillain-Barre from this vaccine. 02/21/2007 records received and reviewed for DOS:12/1/06-02/06/2007 DC DX:Severe form of Guillain-Barre syndrome after HPV vaccine and possible URI. Respiratory failure with prolonged mechanical ventilation and tracheostomy tube placement. Haemophilus influenzae, left lower lobe pneumonia, coag negative staph UTI. Hypertension. Tachycardia associated with dysautonomia now resolved. Presented to PCP with URI around Thanksgiving with associated sinus infection. Began having numbness and tingling in hands days of admission as well as back pain, headache and greater problems walking and began falling over. Able to wiggle her toes but with great difficulty. Pneumococcal vaccine in September/October. HPV vaccine on 11/22/06. Mother has possible MS and possible lupus. Neuro exam:Weakness of deltoid bilaterally, weakness of lower extremities with grade 4/5 weakness at hip flexor, 4/5 hip extension, 4/5 knee flexion, 4+/5 knee extension and 3+/5 plantar flexion. Deep tendon reflexes absent in all extremities even with augmentation. Plantar responses downgoing. Gait abnormal some degree of pelvic girdle weakness and foot drop bilaterally.Began IVIG. On day 2 began developing post void residuals. Vital capacity deteriorated on day 3 to 2.2 increasing difficulties with secretions as her gag and cough diminished. Able to move only jaw and eyes. Intubated and placed on fentanyl and versed. Developed HTN. Developed neuropathic pain. At discharge able to stand with assistance. Off vent on 1/26/07. Tachycardia and hypertension associated with autonomic dysfunction now resolved at discharge. Zyrtec prn, guaifenesin prn, tylenol prn Other Meds: Elevated protein in CSF; clinical symptoms suggestive of Guillain-Barre syndrome (primarily motor weakness, some altered sensation) Head CT normal except Lab Data: for sinusitis. Coag negative staph UTI. CSF: protein 64, glucose 57 and 7WBC. EMG on None that I'm aware of History: Prex Illness: Prex Vax Illns: I don't have this info


Page 322
Vaers Id: 268143-2 (S) Related reports: 268143-1; 268143-3; 268143-4 Age Gender Vaccine Date Onset Date Days Received Date F 21-Nov-2006 30-Nov-2006 9 13.0 05-Dec-2006 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC. Lot 0868F
State WA
Prev Doses 0
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, SERIOUS Guillain-Barre syndrome
Symptom Text: Cannot walk. This is a previously well 13-year old female who yesterday noticed some numbness and tingling of her toes and feet. Today it is extended a little higher,and she has noticed her hands and fingers being somewhat numb. In additions, today she has difficulties feeling her legs and needs to walk with assistance because she claims she has no sensation in her legs. Six days ago, she had symptoms of a headache, nausea, and some nasal discharge. She was seen at the Fairchild Air Force Base clinic and given Zithromax for otitis media. The next day she developed hives and was instructed to stop Zithromas and given Benadryl. The hives diminished and she was given amoxicillin to start the following day. Two days ago, her eyes became somewhat injected and had some mattering. In addition, patient is complaining of some hip and back pain, and her face feels "bruised". She has had emesis twice today but no fever. She has had a facial rash on her right cheek and behind her right ear. Likely early Guillain Barre. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 323
Vaers Id: 268143-3 (S) Related reports: 268143-1; 268143-2; 268143-4 Age Gender Vaccine Date Onset Date Days Received Date F 22-Nov-2006 Unknown 13.0 19-Dec-2006 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC. Lot NULL
State WA
Prev Doses
Site Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS Guillain-Barre syndrome, Urticaria
Symptom Text: Information has been received from a physician concerning a 13 year old female who on 22-Nov-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). A few days later she had cold symptoms and was prescribed azithromycin (ZITHROMAX). A few days after that the patient developed hives and was prescribed amoxicillin. A few days later the patient was hospitalized and diagnosed on 01-Dec-2006 with Guillian-Barre Syndrome. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 324
Vaers Id: 268143-4 (S) Related reports: 268143-1; 268143-2; 268143-3 Age Gender Vaccine Date Onset Date Days Received Date F 15-Aug-2006 30-Nov-2006 107 13.0 14-Mar-2007 VAX Detail: Type MNQ Manufacturer AVENTIS PASTEUR Lot U2114AA
State AK
Mfr Report Id 200603448 Route Unknown
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS CSF protein increased, Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Symptom Text: Initial report received on 11 December 2006, who originally received the report from a health care professional. A 13-year-old female patient, who was taking Zyrtec, Guafanesin, and Tylenol, had received a dose of Menactra log number U2114AA, on 15 August 2006. The route and site of administration were not reported. The patient subsequently received a first dose, intramuscular injection (site unknown) of Gardasil, (lot number not reported), and a Pneumococcal 23valent vaccine, manufacturer unknown, (lot number, route and site of administration not reported) on 22 November 2006. The patient developed Guillain Barre syndrome on 30 November 2006, 107 days post immunization with Menactra, and eight days post immunization with the Gardasil and Pneumococcal 23 valent vaccine. The patient was admitted to the hospital on 01 Dec 2006 with chief complaint of ascending weakness bilaterally, in the upper and lower extremities. Clinical symptoms suggested Guillain Barre Syndrome with primarily motor weakness and some altered sensation. A neurology consult was made, and the patient was diagnosed with Guillain Barre Syndrome. The CSF fluid showed elevated protein. At the time of this report, the recovery status of the patient was unknown. Zyrtec, Guaifenesin, Tylenol Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: The patient was taking Zyrtec prn, Guaifenesin prn, and Tylenol prn at the time of the vaccination on 22 November 2006.


Page 325
State IL
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Dizziness, Vaccination complication, Vertigo, Vomiting
Symptom Text: Gardasil administered 11/27/06, dizziness 11/28/06, severe vertigo 11/29/06, hospitalized 11/29/06-12/01/06. MR received for ER admit for c/o dizziness, vertigo, and vomiting x2 days beginning within 24 hours of Gardasil vax. PE: WNL and in no distress as long as she holds still. Txd with IV fluids, Valium and Antivert. D/Cd home on Meclizine after 48 hours. Discharge DX: Acute vertigo, possible adverse reaction to Gardasil vaccine. 02/05/2007 Tag-2 received. No new codes. Ortho-Evra patch Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Labs and Diagnostics: significant for a serum glucose of 146 (after IV with dextrose) and K+ of 3.3. UA showed 2+blood, 5-10 WBCs. UC showed mixed urogenital flora. HCG (-). CT of brain (-). Previous abnormal pap. PMH: abnormal PAP smear, otherwise healthy. Allergies: NKA.


Page 326
Received Date 02-Feb-2007 Lot 0954F
State IL
Prev Doses 0
Site Right arm
ER VISIT, HOSPITALIZED, SERIOUS Computerised tomogram normal, Dizziness, Feeling drunk, Gait disturbance, Stress, Vertigo
Symptom Text: 2-1-07 Patient states she felt lightheaded the day after her injection. States she felt this was related to stress of school. 2nd day after injection felt "drunk". Terrible walking health center sent her to hospital by ambulance. Admit times 2 days. Diagnosis vertigo, CT Brain WNL was changed with prescription. Medicine - never filled per patient. Too busy with school at finals. No sign of reaction on right deltoid. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Contact hospital mentioned to request information Denies NONE


Page 327
Received Date 07-Mar-2007 Lot 0954F
State IL
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Dizziness, Feeling drunk, Gait disturbance, Malaise, Vertigo
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 22 year old female student who on 27-NOV-2006 was vaccinated 0.5 ml IM in right deltoid with her first of Gardasil, lot #653938/0954F. The day after the vaccination, the patient felt lightheaded. She stated that she felt it was related to the stress of school. The second day after the vaccination she stated that she felt "drunk" and had trouble walking. The student health center sent her to the hospital by ambulance and she was admitted for two days. She had a head computed axial tomography (CT scan) performed which was within normal limits. Her diagnosis was vertigo (onset date reported as 29-NOV-2006). She was discharged with a prescription of meclizine. It was reported that she never filled the prescription because she was too busy with school and finals. There was no signs of reaction on right deltoid noted. No further information is available. UNK Other Meds: head computed axial 11/29?/06 - WNL Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 328
Days 1
State CO
Prev Doses 2
Site Unknown
ER VISIT, OMIC, SERIOUS Abasia, Gait disturbance, Headache, Muscular weakness, Pyrexia, Sensation of heaviness
Symptom Text: Information has been received from an investigator concerning a 12 year old male with migraine headaches who entered a study. On approx 6/16/06 and 8/16/06 and on 11/16/06 at 16:15 the pt was vaccinated with a first, second and third dose of HPV vaccine. On 11/17/06 the pt woke up at 6:40 and went to the bathroom and he reported that he had trouble walking. He returned to bed. The pts father woke him up at 7:45 and noted that he had a fever of 101.3F. the pt stated that his arms and legs were heavy feeling and he didn't think he could walk. the pt experienced muscle weakness. The pts parents call the physician and were advised to take the pt to the ER. The pt went to the ER via ambulance. When the pt arrived the ER his temp was 99.5F (Pt was treated with Advil at home. It was noted that the pts neurosigns were normal and the pt reported to have a headache but refused Imetrex. the pt was discharged and no further tests were done. On 11/17/06 the pt recovered. The reporting investigator felt that muscle weakness was related to study therapy. Muscle weakness was considered to be an other important medical event (OMIC). UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Body temp 11/17/06 101.3F and 99.5F Migraines


Page 329
Days 0
State WI
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Blood pressure increased, Dizziness
Symptom Text: After second dose of a 3 dose series, pt blood pressure increased from normal baseline of 100/60 to 185/135 approx 15-20 minutes after receiving the Gardasil. Pt had near syncopal episode. PT recovered very quickly after ward. Ortho Tri Cyclen Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 330
Vaers Id: 268271-1 (S) Age Gender Vaccine Date F 09-Nov-2006 19.0 VAX Detail: Type HPV4
Days 10
State PA
Prev Doses
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Myalgia, Rash, Skin discolouration
Symptom Text: Information has been received from a physician concerning a 19 year old female with no pertinent medical history or drug reactions allergies, who on 11/9/06 was vaccinated at her OB/GYN's office with HPV vaccine. Concomitant therapy included Zyrtec and oral hormonal contraceptives (unspecified). On 11/19/06 the pt developed a rash on the injection site arm, but not at the injections site. On 11/19/06 the pt also experienced extreme myalgia in all four extremities and her hand was discolored (purple). On 11/20/06 lab testing revealed a positive Rapid streptococcal test and the pt was placed on unspecified antibiotics. Other lab findings revealed a neg medical panel, a complete blood count revealed an elevated WBC count with a shift to the left, and a urinalysis was neg but with a trace hemoglobin. At the time of this report, the pt was recovering. The physician felt that one or more of the events were disabling. Additional information has been requested. Zyrtec, Hormonal contraceptives. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Medical panel neg, trace hemoglobin 11/20/06, rapid streptococcus positive, WBC count elevated 11/20/06.


Page 331
Days 91
State IL
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Convulsion
Symptom Text: Information has been received from a physician concerning a 21 year old female with an allergy to penicillin. Who on 8/16/06 was vaccinated with the first dose of HPV vaccine. Concomitant therapy included unspecified birth control pills (since 2005). On 11/22/06 the pt was seen by the physician and was scheduled to receive her second dose of HPV vaccine. At that time the pt reported to the physician that the week prior (date not specified) she had suffered a seizure. The physician clarified that the pt had no prior history of seizures and that the pts general health was very good. The physician did not give the pt the second dose of vaccine because she was unsure if the seizure could have been related to the first dose of the vaccine. At the time of this report the pt had recovered from the seizure. Upon internal review the seizure was felt to be an other important medical event (OMIC). Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy.


Page 332
Days 0
State TN
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, OMIC, SERIOUS Hypersensitivity, Injection site rash, Wheezing
Symptom Text: Information has been received from a registered nurse concerning a 13 year old female with an allergy to amoxicillin who on 10/27/06 was vaccinated IM with the first dose of HPV vaccine (lot 653650/0702F). There was no concomitant medications. On 10/27/06 approx 10 minutes after the injection, the pt started to break out in a rash around the injection site. The pt then started to wheeze. The pt was given Benadryl and Depo Medrol injection. however continued to wheeze. The wheeze was then relieved by a unit of Xopenex nebulizer treatment, but after ten minutes the pt started to wheeze again. The pt went to the ER and was admitted to the hospital. The nurse reported that th event was that of a standard allergic reaction. The pt was released from the hospital the next day, however had to continue with albuterol inhaler and prednisone therapy. The pt recovered by 10/29/06 and had not experienced any further complications. The nurse reported that the pt would not be receiving any further vaccinations with HPV vaccine. The events were felt to be other important medical events (OMIC) and immediately life threatening. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 333
Onset Date Unknown
Days
State MA
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, OMIC, SERIOUS Epistaxis, Headache, Platelet count decreased
Symptom Text: Information has been received from a physician concerning a 21 year old female with no history of drug reactions/allergies, and a history of idiopathic thrombocytopenic purpura who on 9/25/06 was vaccinated IM with HPV vaccine (Lot 653735/0688F). There was no concomitant medications. In Sept 2006, a few days after vaccination the pt experienced a headache, nose bleed and developed thrombocytopenia. The pts platelet count on an unspecified date was 43,000. The pt was hospitalized and received platelet transfusion. A CT of the head and lumbar puncture were performed, however the results were unspecified. The pt subsequently recovered on an unspecified date. The reporting physician felt that one or more of the events was an other important medical event (OMIC) and life threatening. Additional Information has been requested. NONE Other Meds: Head computed axial 9/6 unspecified, spinal tap 9/06 results unspecified. Platelet count 9/06 43000 Lab Data: History: Prex Illness: Prex Vax Illns: Idiopathic thrombocytopenic purpura.


Page 334
Days 0
State CO
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Convulsion
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 11/21/06 was vaccinated with an initial dose of HPV Vaccine IM in the deltoid. On 11/21/06, after the initial dose, the pt experienced a seizure. The pt was alert shortly after the event and was sent to the emergency department as a precaution. It is unk if the pt was admitted to the hospital. The pt is recovering from seizure. The pt will not continue with subsequent doses of vaccine. Upon internal review, seizure was considered an other important medical event (OMIC). Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 335
Days 0
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Pain, Paraesthesia
Symptom Text: Injection left deltoid with HPV vaccine, immediate pain, transient finger tingling. Pain persists with movement and pressure only, 10/27/06. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 336
Related reports: 268459-2 Vaccine Date Onset Date 05-Dec-2006 05-Dec-2006 Manufacturer MERCK & CO. INC.
Days 0
State NJ
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Cold sweat, Difficulty in walking, Disorientation, Dizziness, Dyskinesia, Headache, Hyperventilation, Pallor, Paraesthesia, Tinnitus, Tremor
Symptom Text: With in five minutes of administration complaint of headache, then felt faint. I had my daughter sit down in the waiting room with her head down before we walked out. Not thinking this had anything to do with the vaccine. We walked out the door and she began have difficlty walking, weaving, I asked her if she was okay and she could only respond yes. I took her arm and tried to turn her back to the Doctor's office and she collapsed on the ground. Though, she remainded conscious her eyes were glazed and was disoriented. It happened that another lady was leaving the office and I asked for her assitance to walk her back inside. The nurse immediately had us put her on an exam table. I do not think she was able to hear a blood pressure. At this point, my daughter was extremely pale, clammy, shallow rapid breathing, weak pulse, able to anwser questions. She stated her ears were ringing and that she had tingling in her feet. The doctor naturally examined her as well. They treated her with oral fluids, rest and some sugar cookies(the only thing they had). I am not sure the exact time the vaccine was administered. I believe it was around 5pm. When we left the doctors office, it was 5:45, my daughter felt weak and was shaky (visible). On the drive home she experienced visible muscle contractions in her arms and legs. Legs and arms were involuntarily jerking. This lasted approximately 10 minutes. By 6:00pm she felt "normal". none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none Shellfish none


Page 337
Days 0
Received Date 09-Jan-2007 Lot 0955F
State NJ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthenia, Dyskinesia, Headache, Hyperhidrosis, Injection site pain, Loss of consciousness, Malaise, Pallor, Tremor
Symptom Text: Information has been received from a nurse at a physician's office concerning a 14 year old female with no medical history reported. On 05-Dec-2006, the patient was vaccinated with the first single dose vial of HPV vaccine (yeast) (Lot#653978/0955F). It was reported that the patient was "alright at the time of the vaccination". However, the patient on her way out of the physician's office stated that she wasn't feeling well (conflicting information reported as "almost immediately after being vaccinated"), the patient developed a bad headache within seconds and began to turn white, The nurse reported that the patient left the office and by the time she got back out to the parking lot, the patient passed out. The physician's office brought the patient back to the office to be examined. The nurse reported that the patient had developed hypotension, tremors, a bad headache, involuntary movement of her upper and lower extremities which lasted about ten minutes along with some additional symptoms which were not specifically specified. The patient became pale, diaphoretic and felt weak. The patient had no vomiting and had no fever. The physician stated that the patient's experience was not an active seizure. Her blood pressure was initially 60/40 mmHg, then later 80/60 mmHg. The patient was not tachycardic. The patient developed pain at the office site of injection. The physician noted that the patient had not eaten for awhile and the patient felt better after eating. The patient was not seen in the emergency room and was fine the next day. Unspecified medical attention was sought. The physician stated that she did not see the "involuntary movement of her upper and lower extremities", which was reported by the nurse. The physician was not in the from at that time to see that, however, she stated again this was not a seizure. The nurse reported that the patient stayed home from school on 06-Dec-2006 because she still was not feeling herself but was "doing better". The nurse reported that the patient was not planning to r UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure 12/05/2006 80/60 mmHg, blood pressure 12/05/2006 60/40 mmHg NONE


Page 338
Days 0
State MD
Prev Doses 1
Site Unknown
ER VISIT, OMIC, SERIOUS Abortion, Laboratory test abnormal, Unintended pregnancy
Symptom Text: Information has been received from a healthcare worker for the pregnancy registry for HPV vaccine concerning a 22 year old female pt whit a history of abnormal pap who on 6/29/06 was vaccainted with her first dose of HPV vaccine , lot 653650/0697F. On 9/5/06 the pt was vaccinated with her second dose of HPV vaccine, lot 653650/0702F. The reporter indicated that the pt received the 2nd vaccination but did not realize she was about 6 weeks pregnant at the time. Medical attention was sought. An ultrasound and colposcopy was performed. The reporter indicated that there was no fetal pole at the time of the ultrasound and that it would be repeated. There was no adverse experience reported. Follow up information has been received from a physician concerning the female pt, whose last menstrual period was approximately 9/9/06. The estimated date of conception was 8/30/06. An ultrasound performed 9/20/06 showed 16P 5 wk 3 days. This is the pts first pregnancy. The estimated delivery date is 5/21/07. Follow up information has been received. On 11/8/06 the pt underwent an elective termination of her pregnancy at 12 week from LMP. Upon internal review, elective termination of pregnancy was considered to be an other important medical event (OMIC). Additional information is not expected. UNK Other Meds: Colposcopy 9/06, ultrasound 9/06/06 no fetal pole, ultrasound 9/20/06 16P 5 wk 3 days. Lab Data: History: Prex Illness: Prex Vax Illns: Papanicolaou smear abnormal.


Page 339
Vaccine Date 04-Dec-2006
Onset Date 05-Dec-2006
Days 1
Received Date 07-Dec-2006 Lot U2094AA 0637F
State MN
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Injection site reaction, Pruritus
Symptom Text: Local pruritic reaction at injection site without erythema, edema left deltoid. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Allergic to Septra NONE


Page 340
Days 1
Received Date 08-Dec-2006 Lot C2457AA 0637F
State CA
Prev Doses
ER VISIT, NOT SERIOUS Dizziness, Headache, Insomnia, Syncope
Symptom Text: Several hours after vaccines given pt complained of HA and dizziness, insomnia. Next am s/s worse fainted. taken by paramedics to Hospital ER on 12/6/06. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE CT Scan


Page 341
Days 16
State CA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Contusion, Pruritus, Rash
Symptom Text: Approx. two weeks after I received the HPV vaccine I started breaking out in red bumps mostly all over my lower body and now I have this weird purple spots on my right thigh. It has itched me so bad that I have bruises all over my legs. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to penicillin, which I told the doctor.


Page 342
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Condition aggravated, Convulsion
Symptom Text: Information has been received from a physician concerning a female pt with seizures who in approx Oct 2006, about two months ago, was vaccinated IM with a first 0.5ml dose of HPV vaccine. Right after receiving the vaccination, the pt started to have seizures every day for about two weeks after receiving the vaccine. It was noted that the pt already has seizures but had them once or twice a week not everyday. Subsequently, the pt recovered. Upon internal review, seizures was considered to be an other important medical event (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Convulsions


Page 343
Days 8
State MI
Prev Doses 0
ER VISIT, NOT SERIOUS Rash erythematous
Symptom Text: One week after injection, pt. has had a patchy, dry, erythemous rash 1 cm. in circumference show up intermittently on trunk and extremities. Rash remits and recurs. No history of rash. Zithromax, Orthotrycyclen Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Allergy to Cephalosporins, Penicillin and Sulfa Dysmonorrhea, Sinusitis


Page 344
Days 1
State FL
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Diplopia, Vision blurred
Symptom Text: Information has been received from a health professional concerning a 28 year old female speech language assistant with no illness at the time of the vaccination and a history of cardiac murmur and migraine who on 07 Nov 2006 was vaccinated with first dose of HPV vaccine (lot 653735/0688F) in the right deltoid at approximately 1100 hours. On 08 Nov 2006, the patient called the medical facility and complained of experiencing blurred vision. On 09 Nov 2006, the patient experienced seeing double. The patient was told to go to the emergency room immediately. On 12 Nov 2006, the patient recovered. It was reported that the events required medical/surgical intervention (other important medical Events) (OMIC). No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Cardiac murmur, migraine.


Page 345
Days 2
State NY
Prev Doses 0
Site Unknown
ER VISIT, OMIC, PERMANENT DISABILITY, SERIOUS Asthma, Chest pain, Condition aggravated, Dyspnoea
Symptom Text: Information has been received from a licensed practical nurse concerning a 14 year old female with asthma, no allergies and a history of vomiting, fever and abdominal cramps after a flu vaccination each time she was vaccinated. The nurse reported that the patients asthma was under good control for more than six months. She also noted that due to the side effects of the flu vaccination, the patient refused to received any more flu shots. On 31 Oct 2006 the patient was vaccinated intramuscularly with a first dose of HPV vaccine (lot 653938/0954F). concomitant therapy included Advair and albuterol inhaler prn. On 02 Nov 2006 the patient had an asthma attack. She developed chest tightening, wheezing and chest pain. The symptoms began after playing basketball. She used her albuterol inhaler with no relief. She went to the ER and was given albuterol and Advair. An EKG and chest X ray were preformed. The patient was not hospitalized. The nurse felt that this asthma attack was an isolated event. She noted that the patients physician felt that it was probably a coincidence that it was after the HPV vaccination. On 04 Nov 2006 the patient recovered. No product quality complaint was involved. The reporter did not considered this asthma attack to be permanently disabling, but that it was disabling because the patient missed school and the shortness of breath during the attack would be considered disabling. Asthma attack was considered to be an other important medical event (OMIC). Additional information has been requested. Albuterol, Advair Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: MEDICAL HISTORY: Immunization, Vomiting, Fever, Adverse drug reaction, Abdominal cramp. CONCURRENT CONDITIONS: Asthma


Page 346
Days 0
State WY
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Influenza like illness, Vomiting
Symptom Text: Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the afternoon of 10 Oct 206 was vaccinated IM with her first dose of Gardasil (yeast), lot #653650/0720F, and experienced flu-like symptoms and vomiting. No medical attention was sought. Within a day or two, the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 347
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
Symptom Text: Initial and follow up information has been received from a Nurse Practitioner concerning an approximately 22 year old female patient who in October 2006, was vaccinated IM with a dose of Gardasil (yeast). Subsequently, she experienced nausea, lightheadedness/lightheaded feeling/dizziness, weakness, pallor, and sweating but did not lose consciousness. No medical attention was sought. The nurse practitioner indicated the patient was "doing fine", and had recovered after 20 minutes. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 348
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Haemorrhage, Injection site induration
Symptom Text: Information has been received from a health professional concerning an approximately 48 year old female patient with condyloma with mild to moderate dysplasia who on 31 Oct 2006 was vaccinated IM into the deltoid with a second 0.5mL dose of Gardasil (yeast) (lot # 653978/0955F). Concomitant therapy included aspirin. It was reported that after the nurse gave the injection blood immediately ran out of the site and it was hard and lumpy. It was reported that the nurse used proper placement technique and a standard 1 inch needle (not the prefilled device). The patient had no problems with the first dose. The patient did not report any discomfort from the hard and lumpy area. The patient sought unspecified medical attention. Additional information has been requested. aspirin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Condyloma, dysplasia


Page 349
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 mL dose of Gardasil (yeast). Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 350
Days 0
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site mass, Pruritus
Symptom Text: Information has been received from a medical assistant concerning a 24 year old female with no other relevant history reported. On 19 Oct 2006, the patient was vaccinated with the first dose of Gardasil (yeast). There were no other concomitant medications reported. On 19 Oct 2006, the patient developed some initial itching at the injection site that resolved (date unknown). On 02 Nov 2006, the patient reported that she awoke with a large red bump at the injection that was itchy "this developed about 13 days post dose". The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 351
Days 1
State IL
Mfr Report Id WAES0611USA01335 Route By Mouth
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pruritus genital
Symptom Text: Information has been received from a nurse concerning a 12 year old female who on 30 Seo 2006 was vaccinated with the first 0.5 mL dose of Gardasil reported as "oral". On 01 Oct 2006, the patient developed intense vaginal itching. The patient sought unspecified medical attention. On 03 Oct 2006, the patient recovered from the event. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 352
Onset Date Unknown
Days
State CT
Prev Doses
Site Unknown
Symptom Text: Information has been received from a female physician assistant (age not reported) who on an unspecified date was vaccinated with 1 dose of 0.5 ML of Gardasil (yeast) (Lot#653978/0955F). The physician assistant reported that after she was injected with Gardasil (yeast) she felt numbness from the injection site progress all the way to her fingers. Unspecified medical attention was sought. At the time of this report, the physician assistant had recovered from the event (date unknown). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 353
Days 0
State IL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Oedema peripheral, Urticaria
Symptom Text: Information has been received from a health professional concerning a her 19 to 21 year old daughter who on approximately 21 Sep 2006 "about 6 weeks ago" was vaccinated IM with a first dose of Gardasil (yeast). Within 5 to 6 hours of vaccination, the patient developed hives and swelling of her hands and feet. The patient was given (Benadryl) and the symptoms began to heal. Subsequently, the patient recovering. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 354
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning the experience of another physician's patient. On an unspecified date, a 12 year old female was vaccinated with a dose of Gardasil (yeast). Subsequently the patient developed a rash on her arm. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 355
Days 1
State IN
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Rash
Symptom Text: Information has been received from a physician concerning a female who on an unspecified date received the first dose of Gardasil (yeast) (Lot # not provided). On 02 Nov 2006 the patient was vaccinated with the second dose of Gardasil (yeast) (Lot # not provided). On 03 Nov 2006 the patient experienced joint pain and developed a rash. Unspecified medical attention was sought. At the time of this report the patient was recovering from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 356
Days 0
State ND
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Oedema peripheral, Pain, Urticaria
Symptom Text: Information has been received from a physician concerning a 14 year old female who on 01-Nov-2006 was vaccinated with 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0640F). At the same time, the patient received medroxyprogesterone acetate (DEPO-PROVERA) " in glut". On 01-Nov-2006 (conflicting information also reported as 02-Nov-2006), the patient developed body aches. On 03-Nov-2006 the patient developed hives all over body and also experienced ankle swelling. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. DEPO-PROVERA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 357
Onset Date Unknown
Days
State SC
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was vaccinated with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The next morning, the patient felt sick to her stomach. It was noted that once she went to school she felt better. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 358
Days 0
State IL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Body temperature decreased, Headache, Nausea, Pain
Symptom Text: Information has been received from a nurse concerning a 19 year old female patient who is the daughter of one of the office employees, who on 02-Nov-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0696F). Concomitant therapy included hormonal contraceptives (unspecified). On 02-Nov-2006 the patient developed nausea, low grade fever, achiness and a headache post vaccination. It was reported that these events continued into the evening on 02-Nov-2006. On 03-Nov-2006, the next morning the patient had recovered from all of the events. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 359
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a Nurse Practitioner concerning a female patient who on 27-Oct-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient fainted in the office, hit her head on the floor and required stitches. Medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 360
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Pain
Symptom Text: Information has been received from a nurse concerning a female who was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness and pain in her arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from pain in injection arm and is recovering from the numbness. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 361
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 362
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Feeling abnormal
Symptom Text: Information has been received from a health professional concerning a 20 year old female who on 26-Oct-2006 was vaccinated "in the right hip" with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#654540/0800F). Within 15 minutes, the patient experienced a "funny feeling" in upper right thigh. The patient said "the feeling was gone later that day". No medical attention was sought. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 363
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Paraesthesia
Symptom Text: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite tingling" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 364
Days 1
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Menorrhagia, Migraine, Rash
Symptom Text: Information has been received from an office manager concerning a 14 year old female who on 02-Nov-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 03-Nov-2006 the patient started her menses and experienced a migraine. On 06-Nov-2006 the patient experienced a rash on her vaccinated arm which also spread to her face. Unspecified medical attention was sought. The patient was treated with diphenhydramine (BENADRYL) and the rash had subsided. AT the time of report, the patient was recovering from the migraine. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 365
Onset Date Unknown
Days
State IN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Face oedema, Oedema peripheral
Symptom Text: Information has been received from a physician concerning a 13 year old female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced swelling in her face, stomach was extended with fluids and her lower extremities were swollen. Unspecified medical attention was sought. The patient was put on "hydrosteroids". She is scheduled for a follow-up visit the week of November 13th. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 366
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Smear cervix abnormal
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient's pap smear came out positive. Medical attention was sought. Her outcome was unknown. Additional information has been requested. UNK Other Meds: Pap test - positive Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 367
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently, two weeks following vaccination, the patient experienced pain at the injection area. The patient also complained of pain in the same area when lifting her arm. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 368
Days 7
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Injection site pain, Swelling
Symptom Text: Information has been received from a physician concerning an approximately 18 year old female who on approximately 02-Nov-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On week after vaccination, on approximately 09-Nov-2006, the patient experienced pain at the injection site, and had redness, soreness and swelling. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 369
Onset Date Unknown
Days
State IL
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient (demographics not provided) who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient developed a rash on her face and stomach. The patient sought unspecified medical advice. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 370
Days 0
State OR
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female with low level depression and anxiety and penicillin allergy and sulfonamide allergy who on 30-Oct-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653978/0955F). Concomitant therapy included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN) acetaminophen (TYLENOL). On 30-Oct-2006, following vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered and no other symptoms were noted. Additional information has been requested. TYLENOL, LEXAPRO, CLARITIN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE CONCURRENT CONDITIONS: Depression, Anxiety, Penicillin allergy, Sulfonamide allergy


Page 371
Days 0
State AZ
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning an 15 year old female with a history of polycystic ovary syndrome, who on 12-Sep-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested. DESOGEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CONCURRENT CONDITIONS: Polycystic ovarian syndrome


Page 372
Onset Date Unknown
Days
State CO
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Lymphadenopathy
Symptom Text: Information has been received from a physician's assistant concerning a 11 year old female who on unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient developed swollen lymph nodes in groin her area. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 373
Days 0
State NJ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Anxiety, Hyperhidrosis, Injection site erythema, Injection site swelling, Lymphadenopathy, Nausea, Pain, Paraesthesia, Pruritus, Pyrexia
Symptom Text: Information has been received from a physician concerning his daughter, a 19 year old female who at 15:00 on 08-Nov-2006 "was feeling great anxiety" before receiving an intramuscular injection with the vaccination HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). On 08-Nov-2006 after receiving the vaccination the patient experienced throbbing pain, a tingling sensation down length of her arm, elbow, wrist, jaw line and down her neck, fever, swelling and redness at the injection site, was "terribly itchy", had veins protruding, swollen glands, nausea and "felt hot and sweaty" (the patient was reported to be afebrile). Unspecified medical attention was sought. At the time of the report it was unknown if the patient had recovered. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CONCURRENT CONDITIONS: Anxiety


Page 374
Days 0
State CA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Migraine
Symptom Text: Information has been received from a physician concerning a 15 year old female with asthma and penicillin allergy who on 26-Sep-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#not provided). Concomitant therapy included hormonal contraceptives (unspecified). On 07-Nov2006 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#6537361/0868F). That same day the patient experienced a migraine with a "blinded spot in one eye", dizziness and was "seeing stars". She was treated with aspirin. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CONCURRENT CONDITIONS: Asthma, Penicillin allergy


Page 375
Days 0
State UT
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Menstrual disorder
Symptom Text: Information has been received from a physician concerning an 11 year old female who on 05-Sep-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On approximately 05-Sep-2006, the patient noted her menstrual cycle increased from every month to every two weeks. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 376
Onset Date Unknown
Days
State MA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Fall, Fracture, Syncope
Symptom Text: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with Gardasil (yeast). It was reported that the patient was sitting on a bench and when the personnel left the room, the patient apparently fainted and ended up falling off bench. It was reported that it was unsure if the patient had broken her nose but there was blood. At the time of this report, the outcome of the events were unknown. The physician feels that the patient "might be anorexic and had not had anything to eat all day hence the fainting". No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Anorexia


Page 377
Days 0
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Sensation of heaviness
Symptom Text: Information has been received from a mother of an 11 year old female who on 31 Oct 2006 was vaccinated with Gardasil (yeast) (0.5 ml). On 31 Oct 2006, 30 minutes following vaccination, the patient's arm "felt heavy". Subsequently, the patient recovered from the event 30 minutes later. Medical attention was not sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 378
Onset Date Unknown
Days
State WI
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Abdominal pain, Pelvic pain
Symptom Text: Information had been received from a physician concerning a patient who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). Subsequently the patient experienced abdominal pain and suprapubic pain that radiated to the vaginal region. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 379
Onset Date Unknown
Days
State MI
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Abdominal pain, Dizziness, Joint stiffness
Symptom Text: Information has been received from a physician concerning a female (age not reported) with rheumatoid arthritis who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient developed dizziness, stiffness in joints and abdominal cramping. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: CONCURRENT CONDITIONS: Rheumatoid arthritis


Page 380
Days 0
State FL
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician and a nurse concerning a 21 year old female with glaucoma who on 09 Sep 2006 was vaccinated with a first dose of Gardasil (yeast). Concomitant therapy included Xalatan. On 12 Nov 2006, the patient was vaccinated IM, in the right deltoid, with a 0.5 ml second dose of Gardasil (yeast) (lot #653736/0868F). On 12 Nov 2006, 13 hours after the vaccination, the patient developed a rash on both arms. The patient used alcholol on these areas and the rash went away. On approximately 12 Sep 2006, at an unspecified time, the patient developed hives. The hives were itchy and "looked like slap marks all over her body" including her legs, abdomen, back and face. The welts were raised and swollen. The patient was treated with Benadryl. At the time of the report, the patient was recovering from the hives. There were laboratory or diagnostic tests performed. It was reported that the patient had no reactions after the first dose of Gardasil (yeast). Additional information has been requested. Xalatan Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Glaucoma


Page 381
Days 8
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Cellulitis
Symptom Text: Information has been received from a physician concerning a 11 year old female who on 01-Nov-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot #653938/0954F). On 09 Nov 2006 the patient developed cellulitis in the arm where vaccine was administered. Unspecified medical attention was sought. At the time of the report, the patient was recovering from the cellulitis. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 382
Days 0
State VA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Hyperhidrosis, Incorrect route of drug administration, Nausea
Symptom Text: Information has been received from a registered nurse concerning her 16 year old daughter who on 13 Nov 2006 was vaccinated with her first dose of Gardasil (yeast). The patient's mother reported that she was vaccinated subcutaneously. Conflicting information was received from the administering licensed practical nurse who reported that she was positive the patient was vaccinated intramusculaurly into the deltoid area and not subcutaneously. On 13 Nov 2006, a few minutes after the vaccine was administered, the patient experienced nausea, dizziness and sweating. Unspecified medical attention was sought. Subsequentely, the patient recovered from nausea, dizzines and sweating in a few minutes. Additional information has been received from a registered nurse. The nurse reported that her fellow nurse gave the dose of Gardasil (yeast) IM instead of subcutaneous. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 383
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Oedema
Symptom Text: Information has been received from a nurse practitioner concerning a 19 year old female who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil (yeast). The patient was experiencing vomiting and diarrhea and had no fever prior to receiving the vaccination. Subsequently, the patient developed swelling of hands and feet and her face got puffy after receiving Gardasil (yeast). The patient sought medical attention and was treated with an unspecified antihistamine. Subsequently, the swelling went away, and the patient was considered recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK diarrhea, vomiting


Page 384
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil (yeast). Subsequently the patient developed a shooting pain down her arm where she received the injection. Reportedly the physician does not think this is an adverse experience. Subsequently, the patient recovered from shooting pain down her arm in less than a minute. The patient does not want to come back for a second injection. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 385
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who in October 2006, was vaccinated with the first dose of Gardasil (yeast) (0.5mL). In approximately October 2006, "shortly after the injection", the patient was examined and learned that she developed an abnormal PAP. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. UNK Other Meds: Pap test 10/?/06-abnormal Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 386
Days 0
State AZ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Decreased appetite, Vomiting
Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female who on 13 Nov 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (Lot # not provided). On 13 Nov 2006 the patient experienced nausea, vomiting and decreased appetite. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered from these events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 387
Days 1
State NJ
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 16 year old female who on 08 Nove 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (Lot # not provided). On 09 Nov 2006 it was reported that the patient developed hives. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 388
Days 0
State IL
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Oedema peripheral, Pruritus, Urticaria
Symptom Text: Information has been received from a registered nurse concerning a 22 year ld white female student with no other medical history, no known allergies or adverse drug reactions reported. On 26 Sep 2006, at 12:300 PM, the patient was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (yeast) (Lot# 653736/0689F), within 2 hours of the injections the patient developed full body hives, itching and swelling of hands and feet. The patient took Benadryl every 4 hours and the symptoms were gone within 24 hours. At the time of this report, the patient had recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 389
Onset Date Unknown
Days
State WA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Chills, Dizziness, Hyperhidrosis, Nausea, Syncope
Symptom Text: Information has been received from a consumer who is a company representative concerning her 20 year old daughter who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). The patient's mother reported that the vaccination caused the patient to feel faint, and she experienced nausea with chills and sweating. The patient was kept in the office until she felt better. No further details were provided. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 390
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
Symptom Text: Information has been received from a practice manager concerning a female patient who on an unspecified date was vaccinated with Gardisal (yeast). Subsequently, following vaccination, the patient experienced syncope. Unspecified medical attention was sought. No further details were provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 391
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was "shot phobic" who on an unspecified date was vaccinated with Gardasil (yeast) (0.5ml). Subsequently, following vaccination, the patient fainted. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: phobia


Page 392
Days 0
State WA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Fatigue, Headache, Pain, Tinnitus
Symptom Text: Information has been received from a registered nurse at an OB/GYN's office concerning a 14 year old female with penicillin allergy who on 13 Nov 2006 was vaccinated intramuscularly in the left deltoid with Gardasil (yeast) (lot #653938/0954F). There was no concomitant medication. On 13 Nov 2006 the patient experienced pain in the vaccinated arm, headache, dizziness, fatigue, weakness and ringing in the ears. The patient sought treatment from her pediatrician. At the time of this report the patient's pain in the arm, headache, dizziness, fatigue, weakness and ringing in the ears persisted. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Pencillin allergy


Page 393
Days 0
State WA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Headache, Influenza like illness
Symptom Text: Information has been received from a nurse concerning a female who on 13 Nov 2006 was vaccinated with the first dose of Gardasil (yeast). Subsequently on 13 Nov 2006, following vaccination, the patient experienced a headache and flu-like symptoms. The patient did not have a fever. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 394
Days 1
State TN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Abnormal behaviour, Euphoric mood, Malaise, Nausea
Symptom Text: Information has been received from a registered nurse concerning a 13 year old female with a penicillin allergy and drug hypersensitivity to Zithromax. On 14 Nov 2006, the patient was vaccinated with Gardasil (yeast) ( Lot # 653978/0955F). There were no concomitant medications reported. On 15 Nov 2006, the patient was noted to be very emotional, nauseated, felt dazed and "high". The patient sought unspecified medical attention. No treatment was required. On 16 Nov 2006, the patient had recovered from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Penicillin allergy, drug hypersensitivity


Page 395
Onset Date Unknown
Days
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Paraesthesia, Sensation of heaviness
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first 0.5 ml Gardasil (yeast). Subsequently the patient experienced a tingle and heaviness. Unspecified medical attention was sought. After twenty minutes the tingle and heaviness went away. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 396
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Viral infection
Symptom Text: Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated with HPV Vaccine. One week later, the patient was noted to have a positive human papilloma virus infection (date unknown). It was reported that the physician dose not know when the vaccine was given or the dose because she did not administer the vaccine in her office. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Positive HPV test UNK


Page 397
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Menstruation irregular
Symptom Text: Information has been received from a health professional concerning a 20 year old female who on an unspecified date was vaccinated with a dose of HPV Vaccine. Subsequently, the patient experienced three menstrual periods during the next month. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 398
Days 1
State NJ
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 16 year old female with no known drug allergies who on 08 Nov 2006, at 4:00 PM, was vaccinated IM with the first dose of HPV vaccine. On 09 Nov 2006, the patient developed a drug rash. The patient sought unspecified medical attention. On 14 Nov 2006, the patient was recovered from the drug rash. Additional information is not expected. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 399
Days 0
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a female (age not reported) who on approximately 01 Nov 2006 was vaccinated with the first dose of HPV vaccine. On approximately 01 Nov 2006, the patient developed total body itching. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 400
Days 1
State OR
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Nausea, Pyrexia
Symptom Text: Information has been received from a physician's nurse concerning a 15 year old female who on 27 Sep 2006 was vaccinated intramuscularly with HPV vaccine (lot # 653937/0637F). On 28 Sept 2006 the patient experienced nausea, fever and soreness at the injection site. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 401
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site reaction, Urticaria
Symptom Text: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with HPV vaccine. Subsequently, one week later, the patient developed welts on the arm where the shot was administered. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 402
Days 1
State MA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Influenza like illness, Injection site erythema
Symptom Text: Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on 14 Nov 2006 was vaccinated intramuscularly with HPV Vaccine. There was no concomitant medications. On 15 Nov 2006, about 24 hours later, the patient developed erythema at the injection site and experienced flu like symptoms. Unspecified medical attention was sought. Subsequently, the patient recovered from the erythema at injection site and flu like symptoms within 72 hours. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 403
Days 0
State NC
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient (age not reported) with a nerve compression (NOS) who on an unknown date in October 2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV Vaccine (date of first dose and Lot # were not provided). On an unknown date in Oct 2006, the patient experienced numbness in her left arm. The patient was referred to a neurologist, because of her history of pinched nerve. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Nerve compression.


Page 404
Days 0
State AZ
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Blood pressure decreased, Dizziness, Syncope
Symptom Text: Information has been received from a health professional concerning a female patient with an allergy to amoxicillin and clavulanate potassium who on 08 Nov 2006 at 11:00 AM was vaccinated in the right deltoid with the first dose of HPV vaccine. (Lot #654540/0800F) There was no illnesses at the time of vaccination. On 08 Nov 2006, at 1PM, following vaccination, the patient became lightheaded. Then while walking out of the office, the patient had a syncopal episode. It was reported that there was no detectable seizure activity and the patient was not post ictal. The patient's blood pressure was low, however not documented. The patient subsequently recovered with elevation of her feet and after five minutes, the patient was sent home. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood pressure 11/08/06 low. Allergic reaction to antibiotics.


Page 405
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site oedema
Symptom Text: Information has been received from a nurse concerning a female who was vaccinated with a first dose of HPV vaccine. It was reported that immediately upon administration of the vaccine, the patient developed excessive swelling near the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 406
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Breast pain
Symptom Text: Information has been received from a female health professional who was vaccinated with HPV vaccine 0.5ml. Subsequently the patient experienced extremely sore nipples that lasted 4 days. The patient recovered from extremely sore nipples. The health professional plans on receiving the next two vaccine injections. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 407
Days 1
Received Date 18-Dec-2006 Lot NULL NULL
State --
Prev Doses 0
ER VISIT, NOT SERIOUS Chest pain, Erythema, Hypoaesthesia, Injection site erythema, Injection site oedema, Oedema, Pain
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female with a history of drug reaction/allergy to VICODIN who on 27 Nov 2006 was vaccinated with first dose of HPV vaccine injection into left arm. Concomitant therapy included influenza virus vaccine (unspecified) injection also administered the same day on 27 Nov 2006 into her left arm, YASMIN, Minocycline. On 28 Nov 2006, the patient experienced tingling, swelling, and redness in her left arm and hand. She also experienced swelling and redness in her right hand thumb, and some soreness in her chest and upper body area. The patient sought medical attention. No diagnostic tests were performed. Additional information was obtained from the nurse practitioner via phone call. The patient was vaccinated with HPV vaccine and a flu vaccine on 27 Nov 2006 in her left arm by her primary care physician. The patient was seen in her clinic less than 24 hours later experiencing swelling and numbness of fingers, and chest wall discomfort. The patient was seen for follow upon 29 Nov 2006 and all symptoms had resolved. Additional information has been requested. YASMIN, Minocycline Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 408
Days 0
State OH
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female with on approximately 22 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. On 22 Nov 2006 the patient fainted. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 409
Days 7
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Acne
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female who on 08 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. Within one week the patient developed facial acne. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 410
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Malaise
Symptom Text: Information has been received from the mother of a 21 year old female with penicillin allergy who in 2006 was vaccinated with HPV vaccine. There was no concomitant medication. The patient's mother stated that following vaccination, her daughter was sick. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No further information is expected. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 411
Days 27
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Skin papilloma, Viral infection
Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female with vaginal papilloma who in approximately November 2006, was vaccainted with HPV vaccine. Concomitant therapy included trichloroacetic acid. The nurse practitioner reported that the patient was treated wit trichloroacetic acid (strength unspecified) for existing vaginal warts one week after vaccination with HPV vaccine (the warts were existing prior to the vaccination with HPV Vaccine). Three weeks after the trichloroacetic acid treatment, on 28 Nov 2006, the warts appeared raised and very red, which was much different than normal treatment with trichloroacetic acid. Unspecified medical attention was sought. At the time of this report, the patient had not yet recovered. Additional information has been requested. Trichloroacetic acid Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Vaginal papilloma.


Page 412
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of HPV vaccine. Concomitant therapy included birth control pills. Subsequently, the patient experienced a full body rash. At the time of this report, the patient's outcome was unknown. The reporter felt that full body rash was not related to therapy with HPV vaccine. Additional information has been requested. Hormonal contraceptives. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 413
Days 10
State --
Mfr Report Id WARES0611USA07518 Route Unknown
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female with a penicillin allergy who on 16 Nov 2006 was vaccainted with a first 0.5ml dose of HPV vaccine. Concomitant therapy included LOESTRIM. On 26 Nov 2006 the patient broke out into hives. The patient was treated with a steroid and was doing fine. No product quality complaint was involved. Additional information has been requested. Loestrin Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 414
Days 81
State MO
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Face oedema
Symptom Text: Information has been received from a nurse in a physician's office concerning a 17 year old female who in approximately September 2006, was vaccinated with the second 0.56ml dose of HPV vaccine. On 21 Nov 2006, the patient developed swelling of lips and swelling of face. The patient sought unspecified medical attention. On 22 Nov 2006 within 24 hours, the patient had recovered from the events. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 415
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient in her 20's who in November 2006, was vaccinated with a dose of HPV vaccine. Immediately after administration, the patient passed out. Medical attention was sought. Subsequently, the patient recovered. The physician explained that another physician from a different office administered the vaccination to the patient. Additional information has been requested. There was no product quality complaint involved. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 416
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
Symptom Text: information has been received from a health professional concerning a female patient who was vaccinated with a first dose of HPV Vaccine. Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 417
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Rhinorrhoea
Symptom Text: Information has been received from a physician's assistant concerning a 38 year old female with seasonal allergy and no pertinent medical history who on 11 Sep 2006 was vaccinated intramuscularly with a 0.5ml dose of HPV vaccine (lot #653650/0702F). Concomitant therapy included COMBIVENT and CLARITIN D. The patient reported that within days after 11 Sep 2006, she had to use her inhaler on and off since then. The patient called the physician's office and reported a runny nose and stuffiness since the vaccination with symptoms that continued. The patient took allergy medicine and inhaler without relief. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. COMBIVENT, CLARITIN D Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Seasonal allergy


Page 418
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, High-pitched crying, Malaise, Nausea
Symptom Text: Information has been received from a nurse concerning a female co worker (age not reported) who on 28 Nov 2006 was vaccinated intramuscularly in the deltoid with the first single dose vial of HPV vaccine. The nurse reported that the patient had an experience during and immediately after being vaccinated. The nurse reported that when the patient was given the shot, she started screaming almost immediately and reported that she did not feel well. The nurse also reported that the patient felt like she was going to pass out and was feeling nauseated. The patient was sent home from work and was now out a second day from work. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as the patient had not returned to work. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 419
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 420
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 421
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of HPV vaccine. Subsequently the patient fainted. Unspecified medical attention was sought. a short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 422
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dos of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 423
Days 2
State MI
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on approximately 16 Nov 2006 was vaccinated with a 0.5ml IM dose of HPV vaccine. Two days later dosage, on approximately 18 Nov 2006 the patient developed a rash at injection site. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 424
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 425
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 426
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown


Page 427
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown


Page 428
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 429
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified ) was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 430
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite stinging " at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 431
Days 2
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Abdominal pain upper, Decreased appetite, Medication error, Nausea
Symptom Text: Information has been received from a 19 year old female with a history of papilloma viral infection and no known allergies or adverse drug reactions reported. On 22 Nov 2006, the patient was vaccinated with Gardasil vaccine (yeast). There were no concomitant medications reported. On 24 Nov 2006, the patient reported "feeling sick to her stomach, developed nausea and had trouble eating starting two days after receiving Gardasil vaccine (yeast) and the experience had lasted until now". The patient reported that there was a "possibility she could be pregnant", but would not know until 05 Dec 2006. At the time of this report, the patient had not recovered from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Papilloma viral infection


Page 432
Days 26
State MI
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Discomfort, Lymphadenopathy, Malaise, Pyrexia
Symptom Text: Information has been received from a registered nurse concerning a 24 year old female with a penicillin allergy and had no other pertinent medical history reported. On 03 Nov 2006, the patient was vaccinated intramuscularly in the right deltoid with a 0.5 mL of Gardasil vaccine (yeast) (Lot # 653736/0868F). There were no concomitant medications reported. On 29 Nov 2006, the patient was examined by the physician and was complaining of swelling of the right cervical lymph node and low grade fever. The physician ordered a complete blood count (CBC), which was normal. On 30 Nov 2006, the patient was re-examinined and the right cervical lymph node had increased in size and the patient had developed swelling of the right axillary lymph nodes, peri-sternal discomfort and extreme malaise. The physician ordered a throat culture and results were pending. The patient was being referred to her internist for follow up. Unspecified medical attention was sought. At the time of this report, the patient had not recovered from the events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: complete blood cell "normal"; throat culture "results pending" penicillin allergy


Page 433
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Chest pain, Injection site anaesthesia
Symptom Text: Information has been received from a nurse practitioner concerning a 23 year old female who on 29 Nov 2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil vaccine (yeast) (lot#654389/0961F). Concomitant therapy included fluconazole which was started on 29 Nov 2006 for a pre-existing infection. On 29 Nov 2006 the patient experienced chest pains described as subclavian and numbing at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered from the subclavian chest pains and numbing at the injection site on 30 Nov 2006. Additional information has been requested. fluconazole Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK infection


Page 434
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Vision blurred
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil vaccine (yeast). Subsequently the patient experienced dizziness and blurry vision "a short time after her vaccination". Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 435
Days 1
State FL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Myalgia
Symptom Text: Information has been received from a physician concerning an approximately 19 year old female who on 22 Nov 2006 was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast). On 23 Nov 2006, the patient experienced a sore arm for 2 days. It was noted that it started to get better however on 27 Nov 2006 the pain at the injection site returned with radiating pain to the shoulder and shoulder blade. There was no redness or swelling at the site. The patient stated that "it felt like a heavy weight is on my arm." Unspecified medical attention was sought. The patient's pain at the injection site with radiating pain to the shoulder and shoulder blade persisted. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 436
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Contusion, Pyrexia
Symptom Text: Information has been received from a female consumer who on 24 Nov 2006 "one week ago" was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently the patient experienced bruising at injection site and a low grade fever. No medical attention was sought. No diagnostic laboratory studies were performed. The patient's bruising at injection site and low grade fever persisted. No product quality complaint was involved. Additional information is expected. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 437
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine (yeast). Subsequently, the patient developed "total body itching" (date unknown). At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 438
Onset Date Unknown
Days
State MO
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Arthralgia
Symptom Text: Information has been received from a nurse in a physician's office concerning a 15 year old female who in approximately September 2006, was vaccinated with the second 0.5 mL dose of Gardasil vaccine (yeast). On an unspecified date, the patient developed joint pain. Within 24 hours, the patient had recovered from the event (date unknown). Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 439
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with Gardasil vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 440
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with Gardasil vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 441
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 442
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 443
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 444
Onset Date Unknown
Days
State AZ
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Loss of consciousness, Syncope
Symptom Text: Information has been received from a physician concerning an adolescent female (NOS0 who on an unspecified date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 445
Onset Date Unknown
Days
State AZ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning an adolescent female (NOS0 who on an unspecified date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 446
Days 0
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Hyperhidrosis, Nausea
Symptom Text: Information has been received from a Nurse Practitioner concerning a female patient who on 08-Nov-2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, she experienced nausea, light-headed feeling, dizziness, sweating, but did not lose consciousness. No medical attention was sought. The nurse practitioner indicated the patient recovered after 20 minutes. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 447
Days 0
State WY
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Influenza like illness
Symptom Text: Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the morning of 10-Aug-2006 was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot #653650/0702F, and experienced flu-like symptoms. Concomitant medication included doxycline. No medical attention was sought. Within a day or two, the patient recovered. Additional information has been requested. doxycline Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 448
Days 0
State WY
Prev Doses 0
Site Unknown
Symptom Text: Initial and follow up information has been received from a Registered Nurse concerning a female who on the afternoon of 08-Sep-2006 was vaccinated IM with her first dose of HPV vaccine (yeast), lot #653650/0702F, and experienced flu-like symptoms. No medical attention was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 449
Onset Date Unknown
Days
State FR
Prev Doses
Site Unknown
OMIC, SERIOUS Epilepsy
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with HPV vaccine. Subsequently, 5 days after booth dose 1 and dose 2 of HPV vaccine, the patient experienced epileptic seizure. Subsequently, the patient recovered from epileptic seizure. Upon internal review, epileptic seizure was considered to be an other important medical event (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 450
Vaers Id: 269332-1 Age Gender F 16.0 VAX Detail: Type HPV4 HEP
Days 0
Received Date 19-Dec-2006 Lot 0902F ABVB221B
State FR
Prev Doses
OMIC, SERIOUS Agitation, Crying, Dyspnoea, Tongue oedema
Symptom Text: Information has been received from a healthcare professional concerning a 16 year old female patient who on 29 Nov 2006 was vaccinated in the left arm with a dose of HPV vaccine, lot 654884/0902F, batch NE24240. Concomitant suspect therapy included hepatitis B vaccine, Engerix B, batch ABVB221BA, given the same day in the opposite arm. Thirty minutes after administration, while being driven home from the clinic, the patient developed a swollen tongue, difficulty breathing, was panicking and crying. She was treated with Piriton and recovered the same day. The events were considered to be other important medical events as the patient had difficulty breathing (OMIC). Additional information has been requested. Other business partner numbers included E20060652. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 451
Days 4
State CA
Prev Doses 0
Site Right arm
Symptom Text: Itching of entire body 4-5 days after vaccination on 11/22/06. Has continued on and off since then. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergies-Anox, penicillin NONE NONE


Page 452
Days 0
Received Date 19-Dec-2006 Lot 1065F AC52B012AA 0961F
State FL
Mfr Report Id Route Subcutaneously Intramuscular Intramuscular
Type VARCEL TDAP HPV4
Manufacturer MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.
Prev Doses 1 0 0
ER VISIT, NOT SERIOUS Dizziness, Syncope
Symptom Text: Patient felt dizzy after dTaP, Varicella, and HPV administration. She had a syncopal episode lasting seconds, immediately recoverd with stable vital signs. To note patient has a past medical history significant for syncope and did not take her atenolo that morning. She was sent to the ER for fluids and further monitoring. atenolol - but not taken today Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Bp 117/68 HR 85 after incident anxiety syncope none


Page 453
Days 0
Status Date 04-Jan-2007 Site Left arm
State CA
Prev Doses 0
Symptom Text: Hives after given HPV. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 454
Days 48
State --
Prev Doses
Site Unknown
OMIC, PERMANENT DISABILITY, SERIOUS Dry eye, Visual disturbance
Symptom Text: Information has been received from a medical assistant concerning an 18 year old female with a history of dysfunctional uterine bleeding (DUB) and anaemia who on 14 Sep 2006 was vaccinated with HPV vaccine (lot 0800F, batch 654540), 0.5 ml, IM, once. Concomitant therapy included Yasmin. In approximately November 2006 (last couple weeks), the patient experienced extreme eye dryness after receiving HPV vaccine. The patient's eye was so dry that she had a hard time seeing. On an unspecified date, the patient sought unspecified medical attention. Eventually, the patient had a duct implant put in her eyes by a specialist to help with the dryness. The patient was recovering from the event of extreme eye dryness. Extreme eye dryness was considered to be disabling and an other important medical event (OMIC). Additional information has been requested. Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Dysfunctional uterine bleeding, Anemia.


Page 455
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Injection site reaction, Pain, Skin disorder, Urticaria, Vaccine positive rechallenge
Symptom Text: Information has been received from a female physician assistant (age not reported) who on 03 Oct 2006 was vaccinated intramuscularly with the first 0.5ml dose of HPV vaccine. Concomitant therapy included an unspecified therapy for asthma. On 03 Oct 2006, immediately after receiving the HPV vaccine, she developed extreme pain on her skin and broke out in hives all over her body. The physician assistant stated that it felt like a cat clawing on her skin. The physician assistant went to the emergency room and was treated with asthma medication but was not admitted. No ER date was provided. On an unspecified date, the patient was recovering from the events. On 05 Dec 2006, the patient was vaccinated with a second dose of HPV vaccine. Subsequently, the patient developed an outbreak of hives in a circle around the site of injection. At the time of this report, the outcome of the event was unknown. The physician assistant considered the events of extreme pain on her skin and broke out in hives all over her body to be other important medical events as the patient was treated with asthma medication in the ER (OMIC). Additional information has been requested. Therapy unspecified Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma


Page 456
Days 0
Status Date 02-Jan-2007 Site Right leg
State MO
Prev Doses 0
ER VISIT, NOT SERIOUS Dizziness, Nausea, Tremor
Symptom Text: 2:30 gave injection. 2:40 Patient complained of being dizzy and nauseous. Laid patient down with wet cloth on head, gave water. 2:50 took blood pressure 100/52. Patient complains of shakiness. 3:05 No better took to urgent care. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 457
Related reports: 269692-2 Vaccine Date Onset Date 22-Nov-2006 22-Nov-2006 Manufacturer MERCK & CO. INC.
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Abasia, Chills, Pain, Rash, Rash macular, Swelling
Symptom Text: The patient presented to the ER complained of rash, pain, swelling to lower extremities bilaterally. She had developed a maculopapular rash after the vaccination. She was discharged home on Percoat/Prednisone. Chills and unable to walk. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: complete blood count, PT/PTT NONE NONE


Page 458
Vaers Id: 269692-2 (S) Related reports: 269692-1 Age Gender Vaccine Date Onset Date F 22-Nov-2006 22-Nov-2006 18.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Abasia, Chills, Lymphocyte count abnormal, Pain in extremity, Platelet count normal, Rash maculo-papular, Swelling, White blood cell count increased
Symptom Text: Information has been received from a nurse concerning an 18 year old female non-smoker who abstains from alcohol and has no known drug allergies. On 22Nov-2006, the patient was vaccinated with the first dose of Gardasil vaccine (yeast) (lot number 653937/0637F). On 22-Nov-2006 (also reported as 26-Nov2006) the patient experienced maculopapular rash to bilateral lower extremities which started on her thighs and moved down to her feet, swelling to bilateral lower extremities with the right leg larger than the left, deep pain of bilateral lower extremity leg muscles particularly below the knee, and chills. The patient was seen in the Emergency Department on 27-Nov-2006. White blood cell count was 14.1 thou/cc/mm (range 4.0-10.0), platelet count was 361 thou/cc/mm (range 150-450), and lymphocyte count was 12.3% (range 20.0-45.0). The deep pain of bilateral lower extremity leg muscles particularly below the knee was so severe the patient could not walk, and it was considered an "emergency medical condition due to the impairment of bodily function". The patient was discharged to home on Percocet and Prednisone. Subsequently the patient recovered from maculopapular rash to bilateral lower extremities, swelling to bilateral lower extremities, deep pain of bilateral lower extremity leg muscles and chills. Deep pain of bilateral leg muscles particularly below the knee of bilateral lower extremities was considered to be disabling. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: platelet count 11/27/06 361 thou 150-450 lymphoblast count 11/27/06 12.3% 20.0-45.0 WBC count 11/27/06 14.1 thou 4.0-10.0 Non-smoker, abstains from alcohol


Page 459
Days 0
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site erythema
Symptom Text: Immediate after Gardasil given pt developed 4cm bright red area at injection site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 460
Days 0
State WA
Prev Doses 0
ER VISIT, NOT SERIOUS Asthenia, Dizziness, Dyspnoea, Flushing, Nausea
Symptom Text: 1 hour after receiving HPV vaccine became dizzy, skin sensation of burning and flushing all over. Nausea with SOB with talking. Generalized weakness. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE- given Benadryl NONE NONE


Page 461
Days 9
State CA
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Pregnancy test false positive
Symptom Text: Patient pregnancy unbeknownst to provider when vaccine administered. Patient didn't divulge pregnancy test at home. Was positive one month prior. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE urine pregnancy test in office (12-20-06) positive NONE NONE


Page 462
Days 1
State FL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Pruritus, Urticaria
Symptom Text: Patient developed hives starting at injection site and spreading over entire body. + itching. No respiratory symptoms. Patient used Benadryl without relief and was referred to her PCP for follow up. Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Loestrin, Suprax, Pediazol.


Page 463
Days 1
State SC
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Headache, Syncope
Symptom Text: Patient fainted after receiving her second dose of Gardisil Vaccine. Patient c/o headache and pain in back of her head. Returned to office 12/28/06 for exam. Still c/o head pain. To call office prn with followup. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergy Amoxicillin none known


Page 464
Days 26
State FR
Prev Doses
Site Unknown
OMIC, SERIOUS Headache, Venous thrombosis, Visual disturbance
Symptom Text: Information has been received from a physician concerning his daughter a 22 year old female who on approximately 15 Oct 2006 (mid October 2006) was vaccainted with first dose of HPV vaccine (lot # not reported) intramuscularly into the upper arm. ON approximately 22 Oct 2006 (one week later, end of October 2006) she received a dose of influenza vaccine (manufacturer and lot no unknown). On 10 Nov 2006, the patient developed headache and vision disorder (unspecified). On 20 Nov 2006, a magnetic resonance Imaging (MRI) was performed and thrombosis of the venous sinuses was diagnoses. She was treated with Heparin. To be noted, she was not hospitalized. She recovered within an unspecified time. The reporter considered the event to be serious (other important medical event) (OMIC). Other business partner numbers included E200606931. Additional information is not expected. NONE Other Meds: Magnetic resonance imaging 20Nov06 thrombosis of the venous sinuses. Lab Data: History: Prex Illness: Prex Vax Illns:


Page 465
Days 0
State NY
Prev Doses 0
Symptom Text: Pt called 12/20/06 and reported that on the evening of 12/18/06 she developed generalized itching and hives, no other symptoms. She was instructed to take 25mg Benadryl Q 6H when needed. No further vaccinations will be administered per Dr. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to depacote, Lortab, nuerontin, valicum,


Page 466
Days 0
State NY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 31 year old female with drug allergies to Depakote, Lortab, Neurotin, Valium and Fioricet. On 18-Dec-2006 (also reported as 18-Dec-1976) the patient was vaccinated with her first dose of Gardasil vaccine (yeast) (lot number 654540/1161F), intramuscularly in the left deltoid. On 18-Dec-2006 in the evening, the patient experienced generalized itching, and hives. The patient was instructed to take Benadryl 25 mg every 6-8 hours until the itching subsided. The patient was informed that she will not be receiving the additional 2 vaccinations. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Drug hypersensitivity


Page 467
Days 0
Received Date 02-Jan-2007 Lot NULL
State VA
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Dizziness, Fracture, Injury, Nausea, Syncope
Symptom Text: Information has been received from a 21 year old female with no pertinent medical history or drug reactions/allergies, who on 13 Nov 2006 was vaccinated intramuscularly with HPV Vaccine. Concomitant therapy included Zyrtec and Yasmin. On 13 Nov 2006, following vaccination, the patient felt nauseous and dizzy. As she went out of the room to check out, the patient fainted and broke her nose and got a cut under eye. The patient reported that she was on the floor for seven to eight minutes before she woke up. The patient reported that she had to get her nose fixed and received some stitches afterward. At the time of this report, the patient was recovering. Upon internal review, the facial bones fracture which required surgery was felt to be an other important medical event (OMIC). Additional information has been requested. Zyrtec, Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 468
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, OMIC, PERMANENT DISABILITY, SERIOUS Arthritis, Joint swelling, Myalgia, Urinary tract infection, Viral infection
Symptom Text: Information has been received from a physician concerning her 18 year old daughter with a history of HPV and acne who at the beginning of October 2006, was vaccinated with a dose of HPV vaccine. Concomitant therapy included Yasmin and Minocin. One week later, the patient developed a urinary tract infection. Two weeks after vaccination, she had an acute onset of arthritis. She had significant swelling of her finger joints and generalized myalgia. She had blood work to include viral antibody titers which were positive for parvo virus, Epstein Barr and Cytomegalovirus. The patient was treated with steroids and anti inflammatory drugs. At the time of the report she had not recovered. The reporter considered the events to be disabling and other important medical events (OMIC). Additional information has been requested. Yasmin, Minocin. Other Meds: 10/06 viral antibody titer positive for Parvo virus, Epstein Barr virus 10/06 Positive, Cytomegalovirus 10/06 positive. Lab Data: History: Prex Illness: Prex Vax Illns: Papilloma viral infection, Acne.


Page 469
Vaers Id: 270005-1 Age Gender F 24.0 VAX Detail: Type TYP HEP HPV4 TDAP Seriousness: MedDRA PT
Vaccine Date 03-Jan-2007
Onset Date 03-Jan-2007
Days 0
Received Date 03-Jan-2007
State VA
Manufacturer AVENTIS PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. AVENTIS PASTEUR
Lot Prev Doses Z0664 0 AHBVB259CA 0 0954F C2491AA 0 0
Symptom Text: Patient became very light headed and dizzy w/in moment of vaccine. Patient was observed and released. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE Ortha Evra


Page 470
Days 0
State VA
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Pruritus, Rash, Urticaria
Symptom Text: 15 minutes after IM injection of Gardasil in right arm. Patient developed hives on her neck right side continued to move up on face. 20 minutes post injection rash and then itching over neck, face and back. Benadryl used IM. Vital signs remained stable. Depo Provera times 2 years Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Latex NONE


Page 471
Days 0
State FL
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Hot flush, Nausea
Symptom Text: Patient complain of nausea, light-headed, hot flashes, right after injection. Told patient to lay down on back on the table, took some water about 25 minutes recheck BP and pulse. Ok to leave. Nuva ring Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Ibuprofen NONE


Page 472
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Blindness transient, Dizziness, Headache, Pallor
Symptom Text: information has been received from the mother of a 19 year old female with a drug hypersensitivity to unspecified antibiotics. On 21 Dec 2006, the patient was vaccinated with the first dose of HPV vaccine. There were no concomitant medications reported. On 21 Dec 2006, the patient felt like her head was going to burst, she looked pale and was possibly going to faint. The patient developed temporary blindness that lasted about two minutes. The patient sought unspecified medical attention. On 21 Dec 2006, the patient had recovered from the events, "after a few minutes". Upon internal review, the temporary blindness was considered to be an other important medical event (OMIC). Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CONCURRENT CONDITIONS: Drug hypersensitivity


Page 473
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Abortion, Ectopic pregnancy, Laboratory test abnormal
Symptom Text: Information has been received from a licensed practical nurse concerning a 25 year old female with no drug reactions/allergies, and unknown date of last menstrual period due to irregular periods and a history of 2 live children (number of pregnancies was not reported) who on 25 Oct 2006 was vaccinated with first dose of HPV vaccine. There was no concomitant medication. The patient sought medical attention. Around 25 Nov 2006, (Thanksgiving time), the patient presented to the office. She had an ectopic pregnancy, went to the emergency room and was administered methotrexate to abort the child. She was monitored for several hours and released. The patient was not hospitalized. It was unk if the patient was pregnant when she was vaccinated with HPV Vaccine due to irregular periods, unknown LMP. At the time of reporting, the patient was recovering, her quantitative HCG was at 85, it should be at 2, but was going downward. The reporter felt that the event required intervention to prevent serious criteria (other important medical event) (OMIC). This report is part of the pregnancy registry. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Serum alpha human 12/06 85 Pregnancy; live birth, Pregnancy NOS (LMP unknown), irregular periods.


Page 474
Days 0
State NJ
Prev Doses 0
ER VISIT, NOT SERIOUS Headache, Nausea, Rash, Upper respiratory tract infection, Urticaria
Symptom Text: 12/01/2006 Nausea, headache, urticaria 12/04/2006. URI symptoms developed after rash. Treated with Benadryl, Prednisone, and Zyrtec. Phone call 1 week later, rash completely gone, urticaria due to vaccine VS intercurrent URI. Oral immunotherapy SLIT Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Premature twin, environmental allergies. NONE


Page 475
Related reports: 270065-2 Vaccine Date Onset Date 28-Dec-2006 02-Jan-2006 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Days -360
Received Date 04-Jan-2007 Lot U1974AB 0961F
State PA
Prev Doses
ER VISIT, NOT SERIOUS Headache, Hypoaesthesia, Muscle rigidity, Neck pain
Symptom Text: 17 year old female received Menactra on 12/28/06. On 1/2/06, patient reported pain in neck and head with non-specific bilateral numbness sensation and pain present in lower extremities (thighs, calves, feet (soles)). Bilateral knee and ankle tendon reflexes normal. Also bilateral calf tightness reported. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 476
Vaers Id: 270065-2 (S) Related reports: 270065-1 Age Gender Vaccine Date Onset Date F 28-Dec-2006 04-Jan-2007 17.0 VAX Detail: Type MNQ HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Days 7
State PA
Prev Doses
ER VISIT, HOSPITALIZED, OMIC, SERIOUS Guillain-Barre syndrome, Headache, Hypoaesthesia, Hyporeflexia, Muscular weakness, Neck pain, Pain in extremity
Symptom Text: Initial report received on 03 January 2007 from a health care professional. A 17 year old female patient, with unknown past medical history, had received a left deltoid injection of Menactra vaccine, lot number U1974AB, and a right deltoid injection of Gardasil vaccine, lot number 0961F, on 28 December 2006. Five days post-immunization, the patient reported pain in her neck and head, non specific bilateral numbness sensation and pain in her lower extremities (thighs, calves, and feet (soles)), and bilateral knee and ankle tendon reflexes. Additional information was obtained from the treated physician by the manufacturer on 04 January 2007. The treating physician reported the patient's condition had worsened and now had areflexia. Treatments received and diagnostic tests performed were not provided. At the time of this report, the patient had not recovered. This report was referred by the CBC to the Clinical Immunization Safety Assessment network for follow up. The reporter of this case is the same as for non-serious case 2007-00057, involving a tingling sensation in the feet and thighs following the receipt of Menactra and Gardasil. The patient in case 2007-00057 is the sister of the patient reported in case 2007-00033. (OMIC) 02/01/07-records received and reviewed for DOS 01/04-01/06/07 DC DX:Guillain Barre Syndrome Chief complaint, pain and weakness of lower extremities bilaterally, 8 out of 10 in intensity shooting from below buttock to knew and from heel to toes as well as bilateral calf pain. Paresthesias in her feet bilaterally. Onset was day prior to admission. PE:Neuro:strength 5/5 in all 4 extremities, sensation intact coordination intact, bilateral toes downgoing, gait steady, Romberg negative. RX with neurotin and IVIG. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Labs: WBC 7.3, CPK 67, myoglobin 9, CRP <0.5. ESR 9 LP:glucose 55, protein 22 RBC 0, WBC 0 Lyme antibodies negative, EBV antibodies negative, CMV negative, C.jejuni negative, mycoplasma pneumonia IgM reactive. PMH:GERD. Allergies:Penicillin


Page 477
Days 0
Received Date 04-Jan-2007 Lot C2638AA 0637F
Status Date 08-Jan-2007 Site Left arm Left arm
State CA
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Injection site oedema, Injection site warmth
Symptom Text: Warm to touch with slight elevation at injection site to LT deltoid. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 478
Onset Date Unknown
Days
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Feeling hot, Syncope
Symptom Text: 10 minutes after receiving Gardasil #1-patient became dizzy,hot, blacked out. Patient recovered completely after 20 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 479
Days 1
State CA
Prev Doses 0
ER VISIT, NOT SERIOUS Eye oedema, Oedema peripheral, Pain, Pruritus, Rash
Symptom Text: Pt given vaccine on 12/26. Began to experience generalized pruritis and mild rash on 12/17. By 12/28 had severe urticarial rash requiring oral steroids. Rash did not improved with steroids and antihistamines, and pt developed edema of hands, feet and eyes and some respiratory symptoms on 12/31. Given IV decadron with relief by an outside provider. Symptoms improving but persistent mild rash at time of my recent re-evaluation on 1/2/07. Her hands remain sore. Adderall, Zoloft, Yasmin, Procardia Other Meds: Elevated WBC likely due to steroids. Lab Data: History: Prex Illness: Prex Vax Illns: Attention deficit disorder, depression, allergy to pediazole none


Page 480
Days 1
Received Date 09-Apr-2007
Status Date 01-May-2007
State CA
Last Edit Date 01-May-2007 Other Vaccine
Site Unknown
NO CONDITIONS, NOT SERIOUS Eye oedema, Oedema peripheral, Rash, Respiratory disorder, Urticaria
Symptom Text: Information has been received from a physician concerning an 18 year old white female with an allergy to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (Pediazole) who on 26, Dec 2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) lot # 653735/0688F). The patient had no illnesses at the time of vaccination. On 27, Dec 2006 rash. By 28, Dec 2006, the patient developed severe urticarial rash requiring oral steroids and antihistamines. By 31-Dec 2006 the patient developed edema of hands, feet, and eyes and respiratory symptoms. The patient was seen in the emergency room. Treatment included intravenous dexamethasone (Decadron) with relief. Subsequently, the patient recovered. Additional information has been requested unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: neutrophil count, 01/02/07, 0.7 K/cum 1.5 - 8.5 platelet counts 01/02/07, 437.0 K/cum 130,000- WBC count , 01/02/07, 13.9 K/cum. 4.5 - 12.5 Drug hypersensitivity


Page 481
Days 0
State PA
Prev Doses 0
Symptom Text: Patient passed out/fainted within 5 minutes of HPV Gardasil injection. She came to with smelling salts then fainted again. Ambulance called, transported patient to local hospital. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE History of Turners Syndrome. NONE


Page 482
Vaers Id: 270145-1 Age Gender F 20.0 VAX Detail: Type MNQ HPV4 FLU Seriousness: MedDRA PT
Days 2
Received Date 08-Jan-2007 Lot U2159A NULL U2240A
State NY
Mfr Report Id 2006034630 Route Intramuscular Unknown Intramuscular
Prev Doses 0 0 1
Site Right arm Unknown Left arm
NO CONDITIONS, NOT SERIOUS Flushing, Pruritus
Symptom Text: Initial report received from a health care professional in the USA on 12 December 2006. A 18 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 24 November 2006, the patient called to reports red spots on hands. The patient did not have any illness at the time of the vaccination. She was treated with Benadryl. She was not seen at the doctor's office and has moved. It was reported that she recovered. Nevacor, Birth control pills, Celexa, Clontin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No known allergies


Page 483
Days 0
Received Date 09-Jan-2007 Lot U2108AA 0961F
State WI
Mfr Report Id Route Unknown Intramuscular
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Blood pressure decreased, Dizziness, Hyperhidrosis, Nausea, Pallor
Symptom Text: Patient received vaccines, then felt nauseous, dizzy, was pale and diaphoretic, BP decreased to 80/50, pt placed supine with feet elevated, given Benadryl 20 mg PO, sips water, felt better after about 1 hour. Prozac, Trisprintac Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Labs drawn just prior to vaccines (routine). Depression


Page 484
Days 2
Received Date 09-Jan-2007 Lot AC52B012AA 0960F
State MD
Prev Doses 6 0
Right arm
NO CONDITIONS, NOT SERIOUS Erythema, Feeling hot
Symptom Text: Quarter sized area red and hot to touch at injection site of Tdap. Advised to apply cold compress by on call doctor. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 485
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning a patient who may have been vaccinated with a dose of with HPV vaccine (yeast) (lot#653650/0697F) in which while preparing the syringe for administration, the safety syringe activated prematurely. It was reported that she may have touched the side of the syringe near the fingers and the activated the safety device. It was also reported that the second syringe scared the patient when it pooped down. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 486
Days 0
State IN
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient (age and demographics not reported) who on 01-Dec-2006 was vaccinated with the first dose of HPV vaccine (yeast) (Lot# not reported). On 01-Dec-2006 immediately after being vaccinated the patient developed widespread hives. No respiratory difficulty was noted. The patient was transported to the emergency room for evaluation and was not admitted to the hospital. At the time of this report the patient had not recovered from the hives. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 487
Days 0
State IN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pallor, Urticaria
Symptom Text: Information has been received from a health professional concerning a female patient who on 01-Dec-2006 was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). It was noted that medroxyprogesterone acetate (DEPO-PROVERA) may have been given concomitantly. On 01-Dec-2006 the patient developed hives and turned pale white. She was admitted to the emergency room and there was no further information if she will be admitted. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. DEPO-PROVERA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 488
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently the patient developed a rash 10 minutes after vaccination. The patient was treated with antihistamine. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 489
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Malaise, Pyrexia, Vomiting
Symptom Text: Information has been received from a health professional who was told by her sister in law that in October 2006, a 24 month old patient was vaccinated by mistake with HPV vaccine. It was reported that the patient became very ill and began vomiting and developed a high fever. It was reported that the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 490
Days 0
State OH
Prev Doses 0
ER VISIT, NOT SERIOUS Discomfort, Injection site discomfort, Injection site pain
Symptom Text: Information has been received from a registered nurse concerning her 19 year old daughter with no medical history or drug allergies who on 27 Nov 2006 was vaccinated intramuscularly in the mid top gluteal region with a first dose of HPV Vaccine. There was no concomitant medication. On 27 Nov 2006 the patient mentioned that the site of injection hurt and caused discomfort. The patient was uncomfortable for 24 hours. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 491
Days 1
State LA
Prev Doses 0
ER VISIT, NOT SERIOUS Muscular weakness, Rash
Symptom Text: Information has been received from a physician concerning a 19 year old female with a urinary tract infection who on 28 Nov 2006 at 10:15 was vaccainted IM in the left deltoid with the first dose Gardasil (lot#653938/0954F). Concomitant therapy included CIPRO. On 29 Nov 2006 the patient developed a rash on her face and weakness in her legs and arms. Laboratory results completed the same day included complete blood cell count, blood eosinophilic leukocyte count and white blood cell count which were all normal. Subsequently, the patient "slowly" recovered from the rash and weakness in her arms and legs. Additional information has been requested. CIPRO Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Eosinophil count 11/29/06 complete blood cell 1/29/06, WBC count 11/29/06 all normal. Urinary tract infection.


Page 492
Days 0
State AZ
Prev Doses
NO CONDITIONS, NOT SERIOUS Vision blurred
Symptom Text: Information has been received from an nurse concerning a 21 year old female with allergic reaction to antibiotics (Septra) who on 01 Dec 2006 was vaccinated intramuscularly in the left deltoid with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 01 Dec 2006 about three hours post vaccination the patient developed blurry vision in her left eye. No other symptoms were reported. Unspecified medical attention was sought. At the time of this report the patient had not recovered from the blurry vision. Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic reaction to antibiotics


Page 493
Days 1
State --
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Dizziness, Dysgeusia, Headache
Symptom Text: Information has been received from a nurse concerning a 17 year old female who on 29 Nov 2006 was vaccinated with the second dose (first dose date not reported) Gardasil (Lot 653938/0954F). Concomitant therapy included Adderall tablets and Zoloft. On 30 Nov 2006 the patient experienced dizziness, a bad taste in her mouth and a headache. It was reported that the patient was able to attend school that day. The patient's dizziness and bad taste and headache persisted. It was noted that the patient did not have adverse events after her first dose of Gardasil. The patient sought unspecified medical attention. Additional information has been requested. Adderall Tablets. Zoloft Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 494
Days 1
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Hypersensitivity, Pruritus
Symptom Text: Information has been received from a physician concerning a 24 year old patient who on 27 Nov 2006 was vaccinated in the arm with the first dose of HPV Vaccine. There was no concomitant medications. On 28 Nov 2006, it was reported that the patient developed generalized itching throughout her body. The patient called the physician on the following day and reported she was itchy. The physician stated that she believed the patient experienced an allergic reaction and dose not want to give the second and third shot. It was reported that the patient sought unspecified medical attention. It was reported that a couple of days later, the patient had recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 495
Days 0
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female in her early 20's who sometime in mid November was vaccinated with her first dose of HPV Vaccine. It was reported that within 24 hours the patient experienced numbness in one of her legs and in her arm. The physician stated the patient still had numbness and that it had been over a week now and it had not subsided. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 496
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pharyngeal oedema
Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of HPV Vaccine. Subsequently, the patient experienced throat swelling. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 497
Days 1
State OH
Prev Doses 0
ER VISIT, NOT SERIOUS Blister, Fluid retention, Injection site erythema, Injection site oedema, Urinary bladder rupture
Symptom Text: Information has been received from a nurse concerning a 17 year old female with no medical history or allergies, who on 25 Sept 2006 was vaccinated IM into the left deltoid with a first 0.5ml dose of HPV vaccine (lot 653735/0688F). There was no concomitant medication. Twenty four hours after vaccination, the patient experienced redness and swelling at the injection site and one vesicle was fluid filled and ruptured. Unspecified medical attention was sought. No diagnostic studies were performed. Subsequently, the patient recovered. The nurse stated that the physician will discontinue the therapy and will not be administering any further doses of this vaccine to this patient. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 498
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Swelling
Symptom Text: Information has been received from a medical assistant concerning a female (age not reported) who (approximately one month ago) in approximately November 2006, was vaccinated with Gardasil (yeast). On 04 Dec 2006, the patient just now experienced redness and swelling at what the patient believes is the injection site. The patient had not yet been seen at the office at the time of the reporting. The outcome of the event was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 499
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Chest discomfort, Chest pain, Dyspnoea, Hypoaesthesia
Symptom Text: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies, who on 03 Nov 2006 was vaccinated with Gardasil (yeast) (0.5 ml). There was no concomitant medication. On 03 Nove 2006 the patient experienced shortness of breath, chest pain, chest tightness and numbness in the arm that lasted approximately 30 minutes. Unspecified medical attention was sought. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 500
Vaers Id: 270256-1 Age Gender F 20.0 VAX Detail: Type MNQ FLU HPV4 Seriousness: MedDRA PT
Days 2
Received Date 09-Jan-2007 Lot NULL NULL 0954F
State NY
Mfr Report Id WAES0612USA00864 Route Unknown Unknown Intramuscular
Manufacturer AVENTIS PASTEUR UNKNOWN MANUFACTURER MERCK & CO. INC.
Prev Doses
ER VISIT, NOT SERIOUS Erythema, Flushing, Hypersensitivity, Pruritus, Skin burning sensation
Symptom Text: Information has been received from a physician concerning a 19 year old female with depression, anxiety and hypercholesterolaemia and no history of drug reactions/allergies, who on 20 Nov 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (0.5 mL) (lot #653938/0954F). Concomitant therapy included Seasonale, Mevacor, Celexa, and Xlonopin. Concomitant vaccinations on 20 Nov 2006 included Menactra and influenza virus vaccine (unspecified). 0n 22 Nov 2006, the patient developed facial flushing and chin itching and burning. On 23 Nov 2006, the patient developed red spots on both hands and abdomen. On 23 Nov 2006, the patient sought medical attention at an emergency room while out of town. The patient was diagnosed with having an allergic reaction and administered Benadryl. The patient fully recovered on an unspecified date. Additional information has been requested. Celexa, Klonopin, Seasonale, Mevacor Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE depression, anxiety, hypercholesterolaemia


Page 501
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Initial and follow up information has been received from an RN concerning an 18 year old white female student who on 16 Aug 2006 was vaccinated with her first dose of Gardasil (yeast). It was reported that she experienced pain at injection site several days post injection. On 13 Oct 2006 the patient received her second dose of Gardasil (yeast), IM, lot #653736/0689F. After the injection the patient complained of pain at injection site with radiating pain even at shoulder blade area several days post injection. Medical attention was sought. On 16 Oct 2006 the patient recovered from injection site pain and radiating pain. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 502
Days 0
State TX
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure decreased, Dizziness, Syncope
Symptom Text: Information has been received from an RN concerning an 18 year old female patient with allergies to penicillin and morphine who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Concomitant therapy included Midrin. The patient was " a little lightheaded" during the first injection. On 05 Dec 2006 the patient was vaccinated with her second dose of Gardasil vaccine (yeast), lot # 653937/0637F. She developed syncope less than 10 minutes after the second injection was given. Her blood pressure dropped and she did not awake for 15 minutes. The patient was sent to the emergency room, and the nurse reported she was not sure if she recovered. Additional information has been requested. Midrin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK penicillin allergy, drug hypersensitivity


Page 503
Days 14
State FL
Prev Doses 0
ER VISIT, NOT SERIOUS Anogenital warts
Symptom Text: Information has been received from a Certified Medical Assistant concerning a 22 year old female patient with genital warts and history of abnormal Pap smears who on 21 Nov 2006 was vaccinated IM in the left deltoid with her first dose of Gardasil (yeast), lot #653736/0868F. Concomitant therapy included Ortho Tri-Cyclen Lo. The patient called to report that prior to the vaccination she had 2 undiagnosed "bumps" in the vulva area. Two weeks after the vaccination, on 05 Dec 2006, the patient had an increase in amount of genital warts (3 more "bumps" appeared in the surrounding area). Medical attention was sought. The patient had undergone a Pap smear and cervical biopsy on 21 Nov 2006 (results were not reported). At the time of the report the patient had not recovered. Additional information has been requested. Ortho Tri-Cyclen Lo Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: papanicolaou smear abnormal, genital wart


Page 504
Onset Date Unknown
Days
State NC
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil (yeast). Subsequently, the patient developed a few hives in the upper abdominal area. It was noted that the patient plans to continue with the vaccine series by getting the second and third dose as recommended. Unspecified medical attention was sought. On 04 Dec 2006, the patient recovered. No product quality complaint was involved. Additional informatio has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 505
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning an approximately 22 year old female patient who in 2006 was vaccinated with a first dose of Gardasil (yeast). In 2006, the patient experienced a raised, red, itchy lump at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 506
Days 22
State MS
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 23 year old female who on 01 Nov 2006 was vaccinated with a dose of Gardasil (yeast). On approximately 23 Nov 2006, the patient developed swelling in her lymph node area. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 507
Onset Date Unknown
Days
Received Date 09-Jan-2007 Lot NULL 0688F
State GA
Prev Doses
ER VISIT, NOT SERIOUS Alopecia, Attention deficit/hyperactivity disorder, Eating disorder
Symptom Text: Information has been received from a licensed practical nurse concerning a 17 year old female with an eating disorder and attention deficit/hyperactivity disorder who on 10 Oct 2006, was vaccinated with a dose of Gardasil. The patient was concomitantly vaccinated with a dose of Menactra. Concomitant therapy included unspecified therapy for ADHD. Subsequently, the patient experienced thinning of hair/alopecia. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. (therapy unspecified) Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: eating disorder, attention deficit/hyperactivity disorder


Page 508
Days 0
State TN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Nausea, Pruritus
Symptom Text: Information has been received from a physician and a nurse concerning a 25 year old female who on 06 Nov 2006 was vaccinated intramuscularly with the first single dose vial of Gardasil. On 06 Nov 2006, that evening, the patient developed itching all over her body, but no rash was associated with it. The physician and nurse reported that the patient also developed nausea. Unspecified medical attention was sought. The nurse told the patient to try some over the counter Benadryl to treat the itching as was recommended by the physician. There was no lot number provided. At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 509
Onset Date Unknown
Days
State GA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Alopecia, Hypotrichosis
Symptom Text: Information has been received from a licensed practical nurse concerning a 9 year old female with no pertinent medical history or drug reactions/allergies, who on 05 Sept 2006 and 03 Nov 2006 was vaccinated with the first and second doses of Gardasil (lot 653735/0688F). There was no concomitant medication. Subsequently the patient experienced thinning of hair or alopecia. Unspecified medical attention was sought. At the time of this report the patient had not recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 510
Onset Date Unknown
Days
State FL
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash generalised
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of HPV Vaccine (Lot not provided) Subsequently, the day after she was vaccainted the patient developed a sort of rash all over her body. The physician recommended that the patient treat the rash with Benadryl, which the patient did. subsequently, the rash resolved and no additional treatment was needed. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 511
Days 3
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Menstruation irregular
Symptom Text: Information has been received from a 25 year old female consumer who on 05 Dec 2006 was vaccainted with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). The consumer stated that her period is normally 7 days long, and it started on 04 Dec 2006. On 08 Dec 2006, her period ended. two days earlier than normal. The consumer did not seek medical attention and stated the adverse experience did not improve. Additional information has been requested. Hormonal contraceptives. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK UNK


Page 512
Days 0
State PA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Fear, Pallor, Presyncope
Symptom Text: information has been received from a physician concerning a 16 year old female who on 08 Dec 2006 was vaccinated in the arm with a pre filled syringe of HPV Vaccine. There was no concomitant medication. On 08 Dec 2006, immediately following the vaccination, the patient turned white and nearly passed out. The patient was not hospitalized and was not pregnant. Subsequently, the patient fully recovered. The physician felt that the events were not a result of the vaccine, however a result of the patient being afraid of injections. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Fear


Page 513
Days 0
State AZ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning an 18 or 19 year old female patient who in approximately Nov 2006, was vaccinated with a dose of HPV vaccine. Concomitant suspect therapy included YAZ, an oral contraceptive, which was started at the same time (dose and duration not reported). Subsequently, the patient developed papillary rash and pruritis on lower extremities after Gardasil injection. Medical attention was sought. It was reported that the rash went away after therapy with YAZ was discontinued. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 514
Days 0
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure decreased, Syncope
Symptom Text: Information has been received from an RN concerning a female patient who on 05 Dec 2006 was vaccainted with her first dose of HPV vaccine. While she was receiving the injection she developed syncope and a drop in blood pressure. The nurse reported that the patient recovered and was sent home after 30 minutes. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 515
Onset Date Unknown
Days
State AZ
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Pruritus, Rash
Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with a dose of HPV Vaccine and developed rash and pruritus. The patient's outcome was unknown. Additional information had been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 516
Days 10
Status Date 10-Jan-2007 Site Left leg Right leg
State --
Prev Doses
Symptom Text: Reporter states 19 year old female received Menactra on 12/28/06. On Jan. 7, 2007, patient reported tingling sensation from feet to thighs. Returned to school. Will be seen by physician. not provided Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: not provided unknown


Page 517
Days 10
Status Date 19-Jan-2007 Site Left leg Right leg
State PA
Prev Doses
ER VISIT, NOT SERIOUS Guillain-Barre syndrome, Hyporeflexia, Pain, Paraesthesia, Paraesthesia
Symptom Text: Seriousness criteria other medically significant. Initial information received on 08 January 2007 from a health care professional. A 19 year old female received a dose of Menactra, lot number U1974AB, administered intramuscularly in the left thigh, and ad dose of Gardasil, lot number 0961F, administered intramuscularly in the right thigh on 28 December 2006, Ten days later, on 07 January 2007, the patient developed a tingling sensation from her feet to her thighs. She was seen by a physician and later returned to college in another state. She will follow up with another physician. Her recovery status was not reported. The reporter of this case is the same as for serious case 2007-00033, which involves events of non specified bilateral numbness sensation in lower extremities, areflexia, pain on loser extremities, head pain, neck pain and calf discomfort. The patient in case 2007-00033 is the sister of the patient described in case 2007-00057. Follow up information received on 11 January 2007 from a health care professional. AS based upon the new information obtained in this follow up, the case has been upgraded to serious. The patient's mother had a history of multiple sclerosis. The patient returned from college on Tuesday 09 January 2007 and was taken to hospital, where she was seen by a neurologist. She had decreased reflexes in her lower extremities, as well as sensitivity pain and tingling. She was not admitted to the hospital. She had a spinal tap and CBC in the emergency room and both were negative. She was discharged from the ER and is scheduled to follow up with a physician on 11 January 2007. She may have an EMG during the follow up appointment. The patient has not received treatment for her symptoms. The reporting physician stated that the patient has a working diagnosis of Guillain Barre syndrome, but this has not been finalized. The patient has not recovered from the events. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: A spinal tap and CBC were negative. Information regarding the patients past medical history or concomitant medication use was not provided. It is unknown whether the patient had any illnesses at the time of vaccination. From follow up information received on 11 January 2007, it as reported that the patient's mother had a history of multiple sclerosis.


Page 518
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Injection site erythema, Pruritus, Urticaria
Symptom Text: Information has been received from a nurse practitioner concerning a 19 year old female who on 15 Dec 2006 was vaccainted with her first dose of HPV Vaccine. Subsequently the patient experienced welts on her legs, itching and redness of her injection site arm. The patient was treated with BENADRYL, and she recovered. The patient sought unspecified medical attention. The reporter considered the patient's welts on her legs, itching and redness of her injection site arm to be other important medical events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 519
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, OMIC, SERIOUS Abortion, Unintended pregnancy
Symptom Text: Initial and follow up information has been received from a licensed practical nurse through the manufacturer pregnancy registry concerning a 24 year old female with a history of two miscarriages in the past and not planning on being pregnant, a spontaneous abortion (March 2006) and no known allergies reported. On 20 Nov 2006, the patient was vaccinated intramuscularly in the left deltoid with the first 0.5ml dose of HPV vaccine (lot #653978/0955F). On 20 Nov 2006, the patient had a pelvic ultrasound performed due to pelvic pain. The pelvic ultrasound revealed fluid in pelvis and no intrauterine pregnancy was seen (previously reported as was negative for pregnancy). On an unspecified date, post vaccination, the patient presented to the office stating that she took a urine home pregnancy test and it was positive. On 04 Dec 2006, the patient had blood work drawn which revealed positive for pregnancy. The patient was approximately 6 weeks gestation with last menstrual period noted as approximately 21 Oct 2006. The patient was scheduled for a follow up blood test on 07 Dec 2006 and an ultrasound and blood lab was scheduled on 11 Dec 2006. On 17 Dec 2006 the patient experienced spontaneous abortion. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Upon internal review, the spontaneous abortion was considered to be an other important medical event (OMIC). UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: 12/04/06 blood work positive for pregnancy, 11/20/06 negative for pregnancy, 11/20/06 fluid in pelvis no IUP seen, Urine beta human positive. Miscarriage, Abortion spontaneous.


Page 520
Days 15
State PA
Prev Doses
NO CONDITIONS, NOT SERIOUS Injection site pain, Joint range of motion decreased
Symptom Text: 01/05/07 pt called c/p left arm still sore after 2 weeks after receiving vaccine unable to raise arm over head denies redness or swelling. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Ortho tricyclen LO Pt seen by doctor on 1/6/07 no swelling or redness good ROM REC NSAIDS and warm compresses. RTO 1-2 weeks


Page 521
Days 0
State KY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Loss of consciousness
Symptom Text: Pt has dizziness and then pass out at the office. She was kept for observation her; VS were stable and then discharge home. She still feeling dizziness after later phone call. N/A Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: HPV , Pt with good health. NONE PT HAS FLU LIKE ONE OR 2 WEEKS PREVIOUS IN GOOD HEALTH AT TIME OF VACCINE


Page 522
Days 0
State CA
Prev Doses
Site Right arm
NO CONDITIONS, NOT SERIOUS Feeling hot, Hyperhidrosis
Symptom Text: Pt c/o being hot and sweaty. Pt laid down on exam bed and given water. Pt stayed in clinic for 30 mins and stated she was feeling fine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 523
Days 0
Received Date 11-Jan-2007 Lot 1427F 1213F
State CT
Prev Doses 0 0
Symptom Text: Hives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 524
Days 21
State --
Prev Doses 0
Site Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, OMIC, PERMANENT DISABILITY, SERIOUS Decreased appetite, Dehydration, Diarrhoea, Gastrointestinal disorder, Lymphadenopathy, Vomiting, Weight decreased
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female with no pertinent medical history and no drug reactions or allergies who on 11 Oct 2006 was vaccinated with the first, 0.5 ml dose of HPV vaccine. Concomitant therapy included YAZ. On 11 Dec 2006, the patient received the second, 0.5ml dose of HPV vaccine (lot 653650/0696F). About three weeks after the first dose, approximately 01 Nov 2006, the patient experienced Gastrointestinal problems including, diarrhea, vomiting and decreased appetite. The patient had a swollen right intraglandular lymph node. The patient had lost 12 pounds since the start of her symptoms. The patient was hospitalized overnight and treated for dehydration with intravenous fluids on 12 Nov 2006, 18 Nov 2006 and 31 Dec 2006. laboratory evaluation revealed normal complete blood count and normal ultrasound of the pelvic area. The patient was referred to a gastrointestinal physician but had not been examined yet. At the time of the report, the patient had not recovered. The patient sought medical attention. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be disabling. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be other important medical events (OMIC). Additional information has been requested. YAZ Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 525
Days 1
Received Date 11-Jan-2007 Lot 1052F 09546 AHAVB141AA U1932AB
State NY
Mfr Report Id Route Subcutaneously Intramuscular Intramuscular Intramuscular
Type VARCEL HPV4 HEPA MNQ
Manufacturer MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS AVENTIS PASTEUR
Prev Doses 1 0 0 0
NO CONDITIONS, NOT SERIOUS Erythema, Feeling hot, Tenderness
Symptom Text: Right deltoid erythematous, warm and tender. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 526
Days 0
State FR
Mfr Report Id B0453076A Route Intramuscular Intramuscular
Lot Prev Doses NE24240 AHBVB221BA
OMIC, SERIOUS Dyspnoea, Paraesthesia
Symptom Text: This case was reported by a regulatory authority and described the occurrence of breathlessness in a 16 year old female subject who was vaccinated with Hepatitis B vaccine, HPV vaccine for prophylaxis. On 29 November 2006 the subject received unspecified dose of Hepatitis B vaccine (intramuscular) and unspecified dose of Human Papilloma Type 6+11+18 vaccine (intramuscular). On the same day, 30 minutes after vaccination with Hepatitis B vaccine, at an unspecified time after vaccination with HPV vaccine, the subject experienced breathlessness, oral tingling and tongue tingling. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with antihistamine. On 25 November 2006, the events were resolved. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 527
Related reports: 270405-2 Vaccine Date Onset Date 20-Nov-2006 05-Dec-2006 Manufacturer MERCK & CO. INC.
Days 15
State ID
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Alopecia, Pruritus, Thermal burn
Symptom Text: States feeling like her head was burning and itching. States hair has been steadily been falling out starting 2 weeks post vaccine and continuing over the past two months. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Postpartum x 8 weeks when vaccinated


Page 528
Days
Received Date 15-Feb-2007 Lot NULL
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Alopecia
Symptom Text: Information has been received from a registered nurse (also reported as a physician) concerning a 21 year old female who was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml. Subsequently the patient experienced excessive hair loss. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 529
Days 0
Received Date 11-Jan-2007 Lot 142AA
State MO
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Nausea, Pallor, Syncope
Symptom Text: Patient felt faint, nauseated, pale. Patient laid down symptoms resolved after 10 minutes. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 530
Days 0
State KY
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Nausea, Vomiting
Symptom Text: Five minutes after injection patient became nauseous and vomited. Pulse 100. BP 118/76. Patient waited 20 minutes after vomiting. Felt fine. Left office. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 531
Days 0
Received Date 12-Jan-2007 Lot U2116AA U2271AA 0961F
State NY
Manufacturer AVENTIS PASTEUR AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses
Right arm
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site warmth, Skin ulcer, Tenderness
Symptom Text: Left Deltoid 5cm x 3 1/2 cm circular erythematous tender and warm to touch lesion arm very tender. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Latex allergy.


Page 532
Days 13
State FL
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Abortion, Medication error, Unintended pregnancy
Symptom Text: Information has been received through the manufacturer pregnancy registry and from a medical assistant concerning a 37 year old female who on 09-OCT2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (lot # 653736/0868F). It was reported that on 22-OCT-2006 "the patient discovered she was 7 weeks pregnant) method of confirmation of pregnancy was reported to be a pap smear. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information was received from a medical assistant who reported that on 15-DEC-2006 the patient experienced vaginal spotting. That same day the patient was seen by her obstetrician who performed an abdominal ultrasound. The ultrasound confirmed that there was no fetal heartbeat. On an unspecified date a total serum human chorionic gonadotropin test was performed, results not provided. On 18-DEC-2006, the patient underwent an uncomplicated uterine dilation and curettage as an outpatient. On 02-JAN-2007 the patient was seen by her obstetrician for a postoperative exam which revealed that the patient had a full recovery without complications. The patient was advised to return to full regular activity. Upon internal review, the spontaneous abortion was considered to be an other medical event (OMIC). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 533
Days 0
State KY
Prev Doses
Site Unknown
ER VISIT, OMIC, SERIOUS Abortion, Medication error, Unintended pregnancy
Symptom Text: Information has been received from a registered nurse for the pregnancy registry for Gardasil concerning an 18 year old white female with seasonal allergies and no medical history, who on 16-NOV-2006 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 654540/0800F). Concomitant therapy included DepoProvera and Nasonex. On 16-NOV-2006, the patient's pregnancy test was negative. On 05-DEC-2006, the patient's pregnancy test was positive. It was noted that the patient may have an abortion but that was not related to the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information indicated that the patient's LMP was on 28-OCT-2006 (estimated delivery date is 04-AUG-2007). On 03-JAN-2007 (reported as 03-JAN-2006), the patient had an elective termination. Upon internal review, elective termination was considered to be an other important medical event (OMIC). No further information was available. Depo-Provera; Nasonex Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: beta-human chorionic 11/16/06 - negative; beta-human chorionic 12/05/06 - positive Pregnancy (LMP = 10/28/2006); Seasonal allergy; Contraception


Page 534
Vaers Id: 270530-1 (S) Age Gender Vaccine Date F 16-Dec-2006 36.0 VAX Detail: Type HPV4
Days 0
State FR
Mfr Report Id WAES0701PHL00001 Route Intramuscular
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Erythema, Feeling hot, Hypokinesia, Oedema peripheral, Pain, Skin burning sensation, Skin exfoliation
Symptom Text: Information has been received from a physician concerning a 36 year old female with diabetes who on 16-DEC-2006 was vaccinated with GARDASIL. Concomitant therapy included metformin HCL (HUMAMET) and sibutramine hydrochloride (REDUCTIL). Patient was vaccinated in the morning of 16-DEC2006. Later in the afternoon, the patient experienced swelling, redness and hot feel of both hands and feet. Reportedly, patient could not close fist as it caused pain. On 17-DEC-2006, patient was brought to the emergency room and admitted. Patient was prescribed with descloratadine tablet for 2 weeks and an unspecified ointment. On 19-DEC-2006, patient was discharged. Subsequently, patient experienced peeling of palms and soles. Subsequently, the patient recovered from swelling of both hands and feet. The patient's peeling of palms and soles persisted. The reporting physician and patient felt that swelling of both hands and feet and peeling of palms and soles were related to therapy with GARDASIL vaccine. Additional information has been requested. HUMAMET, Jul06-cont; REDUCTIL, Jul06-cont Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Diabetes


Page 535
Days 0
State --
Prev Doses 0
Site Unknown
OMIC, SERIOUS Convulsion, Crying, Loss of consciousness
Symptom Text: Information has been received from the mother of a 17 year old female patient with acne and pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with an initial dose of Gardasil, injection in the left upper arm. Concomitant therapy included sulfamethoxazole/trimethoprim. On 19-DEC-2006, the patient experienced two seizures after receiving the Gardasil vaccine. The patient's mother reported that the patient "blacked out" about one to two minutes after receiving the injection and was unconscious for about a minute before she experienced the first seizure. The patient had felt nauseous when she had regained consciousness. The patient's mother then reported that the patient "blacked out again" and had the second seizure which was more "severe". When the patient came out of it she started crying. The patient's mother reported that the physician kept them at the office for about three hours to watch her and she was given water. The patient was instructed to see a neurologist. Subsequently at the time of this report, the patient recovered from seizures. Seizures was considered to be an other important medical event (OMIC). Additional information has been requested. Sulfamethoxazole(+)trimethoprim Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood pressure, 12/19/06: 90/60; Blood glucose, 12/19/06: normal; Total heartbeat count, 12/19/06: 62


Page 536
Vaers Id: 270532-1 (S) Age Gender Vaccine Date F 03-Jan-2007 13.0 VAX Detail: Type HPV4
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Blindness transient, Dehydration, Headache, Loss of consciousness, Nausea, Oral intake reduced, Pyrexia, Staring, Syncope, Syncope vasovagal, Vomiting
Symptom Text: Information has been received from a physician concerning a 12 year old female with a penicillin allergy and latex allergy who on 03-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil. Concomitant therapy included Concerta. Later that evening, on 03-JAN-2007, the patient developed nausea and vomited once. At approximately 07:00 am on 04-JAN-2007, the patient developed a headache and temporal blindness that lasted approximately 40 seconds. The patient was taken to the emergency room. At 10:03 am, the patient had a second incidence of headache and temporal blindness that also lasted approximately 40 seconds. At the time of this reported, the patient was stable but was to be admitted to the hospital for observation. At the time of this report, the outcome was unknown. Additional information has been requested. 01/22/07-records received and reviewed from West Boca Medical Center for DOS 01/0407-transferred with DX of new onset seizures to Joe DiMaggio's Children's Hospital. Records requested. CT brain without contrast: negative exam, recommend MRI. 01/30/07-rcords received for DOS 01/04-01/05/07 DC DX: 1. Vasovagal response secondary to dehydration 2. Syncope secondary to #1. Hospital Course: Transferred from West Boca Med Ctr. Admitted with vomiting decreased oral intake since yesterday, complained of blindness and severe headaches this morning with fever of 101.4. Experienced 35-45 second of complaining of blindness, loss of consciousness and staring episode at West Boca Med Ctr. PMH: Status post Kawasaki disease two weeks after developing chicken pox, attention deficit/hyperactivity disorder. Concerta Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CT of brain: normal Urine toxicology normal WBC 6.6, polys 85, lymphocytes 6, monocytes 6, eosinophils 2. Total protein over albumin is 6.9/4.2, calcium 9.2, magnesium 1.9. EEG: normal. Penicillin allergy; latex allergy Status post Kawasaki disease two weeks after developing chicken pox, attention deficit/hyperactivity disorder.


Page 537
Days 4
Received Date 16-Jan-2007 Lot 0868F U2241AA
State KY
Prev Doses 0 2
NO CONDITIONS, NOT SERIOUS Pruritus, Rash generalised
Symptom Text: Four days following the Gardasil vaccine, the patient developed a rash all over her body that was itchy and skin colored. It seemed to be worse on the arm of injections site. The patient received an antihistamine and cortisone creme. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 538
Vaers Id: 270598-1 (S) Age Gender Vaccine Date F Unknown Unknown VAX Detail: Type HPV4
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
ER VISIT, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Anaphylactic reaction, Pharyngeal oedema, Pruritus, Pruritus
Symptom Text: Information has been received from a physician concerning a female who was intramuscularly, vaccinated with the second dose of HPV vaccine. Subsequently the patient developed an anaphylactic reaction (swelling of the throat, itching of hands and feet). At the time of the report, it was not reported if the patient recovered. The physician determined that the patient's anaphylactic reaction (Swelling of the throat, itching of hands and feet) was considered to be immediately life threatening, disabling and an other important medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 539
Days 1
Received Date 17-Jan-2007 Lot 1405F 1095F 0637F
State CA
Type VARCEL HEPA HPV4
Manufacturer MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.
Prev Doses 1 0 0
Site Right arm Right arm Left arm
ER VISIT, NOT SERIOUS Injection site cellulitis
Symptom Text: Cellulitis at injection site right upper arm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE CBC normal NONE NONE


Page 540
Onset Date Unknown
Days
State NY
Prev Doses 0
Symptom Text: 5 mins after receiving Gardasil pt had vasovagal symptoms, lasted approx 5-10 min. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 541
Onset Date Unknown
Days
State MO
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Flushing, Malaise, Skin warm, Somnolence, Vomiting
Symptom Text: 01/04/07 pt started getting sick around 2pm, her face was warm and flush, no recorded fever, threw up one time. Fell asleep until 5pm woke up ate a little dinner went back to sleep until next morning. Birth control Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 542
Days 0
Received Date 17-Jan-2007 Lot C2609AA 0955F
State CA
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Injection site warmth, Pain
Symptom Text: pt stated post last vaccine admin. arm was hot to touch and sore Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none HA, sinus pressure no temp


Page 543
Days 0
State NJ
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Grand mal convulsion
Symptom Text: Information has been received from a 27 year old female consumer with sulfa drug allergy and pertinent medical history reported as none who on 08 Jan 2007 was vaccainted with Gardasil (lot # not reported) 0.5ml injection. Concomitant therapy included Montelukast sodium, ALLEGRA and birth control (unspecified). The consumer reported that on 08 Jan 2007, she had a grand mal seizure after receiving Gardasil. Medical attention was sought. Unspecified blood test were performed. At the time of reporting, the outcome was unspecified. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested. Allegra, Hormonal contraceptives, Singulair. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Diagnostic laboratory 01/08/07 unspecified. Sulfonamide allergy


Page 544
Days 0
State OR
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Erythema, Pallor, Palpitations, Pyrexia, Rash, Rash macular
Symptom Text: 5 hours after receiving HPV pt had low grade fever (99), felt dizzy, pale, had a blotchy red rash on both arms (upper) onto back. No rash elevation, no hives. Pt went to bed, rash was gone by am without further side effects. During episode heart was also pounding. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE History of Dysplasia (hips) NONE


Page 545
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Convulsion, Nausea
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female with a history of two past episodes of seizures (one occurred in 8th grade and another occurred when the patient had her ears pierced) who on 28-Dec-2006 was vaccinated with a first dose of HPV vaccine (yeast) (lot 654389/0961F). The nurse reported that after the dose was administered, the patient felt nausea and while she was lying down, she experienced a "20 second seizure". The patient received unspecified medical attention. The nurse stated that the series would not be completed. At the time of this report, the outcome was unknown. Upon internal review, the patient's seizure was considered an other important medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Convulsion


Page 546
Days 1
Received Date 22-Jan-2007 Lot 0741R
State OH
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Pain in extremity, Pyrexia, Rash macular
Symptom Text: Pain in left arm started four hours after injection could not life or move arm without pain. 24 hours after injection had elevated temp of 100.5 and red blotches below the injection site (but not at the injection site). 72 hours after injection temperature returned to normal and pain was slowly diminishing. 96 hours after injection pain is gone, red blotches are fading. 10 days after injection, red blotches are gone. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE J-Pouch (Ileo-anal anastmosis), Crohn's Disease NONE


Page 547
Onset Date Unknown
Days
State NE
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Chest pain, Dyspnoea
Symptom Text: 36 hrs after vaccine pt had severe chest pain and SOB. Went to ER, Neg EKG and neg CXR. Symptoms resolved on their own. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Depo (also given same day). Neg EKG and Neg CXR


Page 548
Days 1
State NC
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Injection site oedema, Oedema
Symptom Text: Pt's mother called MD office stating that about 36 hrs after 2nd injection, the patient experienced swelling in her right arm that radiated down her arm into finger tips with middle of her back on right side. Her father is MD gave her 10 mg Prednisone with 800 mg Motrin. This was repeated by Dr next day. Manufacturer rep notified. Risperdal Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKDA pt has asthma


Page 549
Days 1
State --
Prev Doses 0
ER VISIT, NOT SERIOUS Chills, Chills, Dizziness, Pyrexia, Tremor
Symptom Text: High fever, shaky, shills, rigors, dizzy. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 550
Days 3
State MI
Prev Doses 0
Symptom Text: Pruritic rash covering majority of body neck down. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Nuvaring, Allegra 180 mg NONE Seasonal allergies NONE


Page 551
Vaers Id: 270921-1 Age Gender M 7.0 VAX Detail: Type IPV HEPA HPV4 DTAP Seriousness: MedDRA PT
Days 1
Received Date 22-Jan-2007 Lot Z0018 1209F 1400F U1985CA
Status Date 23-Jan-2007 Site Right leg Right leg Left leg Left leg
State NC
Mfr Report Id Route Intramuscular Intramuscular Subcutaneously Intramuscular
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 3 0 0 4
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site oedema, Injection site warmth
Symptom Text: Redness, swelling and warmth at site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 552
Days 0
Received Date 23-Jan-2007 Lot 0961F NULL
State --
Prev Doses 1
ER VISIT, NOT SERIOUS Convulsion, Syncope, Vaccine positive rechallenge
Symptom Text: Initial and follow-up information has been received from a physician concerning a year old female with no known allergies and a history of "occasional" migraines who on an unspecified date was vaccinated with the first dose of Gardasil (yeast) (lot number 654540/0800F). Concomitant therapy included hepatitis A virus vaccine (unspecified). Subsequent to the first dose, the patient experienced fainting and "signs of seizure". Clinical outcome was not reported. On 20-DEC-2006 (also reported as 20-DEC-2007), the patient was vaccinated with a second dose of Gardasil (yeast) (lot number 654389/0961F). On 20-DEC2006 (also reported as 20-DEC-2007), the patient experienced fainting. Clinical outcome was not reported. Signs of seizure was considered an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Migraine


Page 553
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Body temperature increased, Dyspnoea, Influenza, Pain
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female who on 04-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml) (lot # 654510/0962F). Subsequently, on 04-JAN-2007, the patient was rushed to the emergency room with symptoms of body aches, breathing problems and a temperature of 103. The patient was released from the emergency room within 12 hours. The nurse reported that the emergency room physician believed that the above reaction was due to influenza. The patient recovered. The reporter considered the patient's experience to be disabling. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 554
Days 0
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Dyspnoea, Erythema, Pruritus, Throat irritation, Urticaria
Symptom Text: Information has been received from a nurse practitioner concerning a 24 year old female with allergic rhinitis, asthma, gastric ulcer, anemia and migraine and a "history of high-risk HPV' who on 10-JAN-2007 was vaccinated with the second dose of Gardasil vaccine (yeast) (lot#655165/1425F), 0.5 ml, one time, IM. Concomitant therapy included NUVARING, ZYRTEC-D and NASAREL. Initial vaccination of Gardasil vaccine (yeast) was received on 16-NOV-2006. On 10JAN-2007, the patient developed throat tickle, chest redness, itchiness, chest and neck hives and intermittent shortness of breath 15 minutes after administration of Gardasil vaccine (yeast). The patient was administered BENADRYL and the symptoms resolved after 10 minutes. The patient left the office in good condition without residual problems. Throat tickle, chest redness, itchiness, chest and neck hives and intermittent shortness of breath were considered to be other important medical events. Additional information has been requested. ZYRTEC-D, NUVARING, NASAREL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: General symptoms Rhinitis allergic, asthma, gastric ulcer, anemia, migraine


Page 555
Days 0
State CA
Prev Doses 0
ER VISIT, NOT SERIOUS Injection site nerve damage, Muscle spasms, Tension
Symptom Text: Pt called on call phone 1/17/07 at 8PM C/O tenseness and spasms to left neck increase spasms when turning head to left. Went to ER that night and was told a nerve may have been hit. Given inj of Valium and anti inflammatory was RX'd Naproxen. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Cipro Hives NONE


Page 556
Days 0
State WI
Prev Doses 0
ER VISIT, NOT SERIOUS Chills, Headache, Injection site pain, Pyrexia
Symptom Text: Onset fever 103.0-103.6 F (orally) 6 hours post injection chills, mild headache, mild pain at injection site. Resolved by 12 hours, except for mild pain at injection site. Oral contraceptives, Zyrtec, Zomig Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Seasonal, environmental allergies, migraine HA, Eczema, Allergies to pineapple, tomatoes, bananas. NONE


Page 557
Days 1
Received Date 24-Jan-2007 Lot 1154F U2082AA 0954F
Status Date 25-Jan-2007 Site Left arm Left arm Left arm
State CA
Type VARCEL MNQ HPV4
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses 1
ER VISIT, NOT SERIOUS Asthenia, Injection site erythema, Injection site oedema, Injection site pain
Symptom Text: Pain, redness, swelling on (L) upper arm, feels weak no fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 558
Days 0
State PA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Flank pain, Nausea
Symptom Text: Pt C/O severe L flank pain with nausea, dizziness 10 min after receiving vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Multivitamin


Page 559
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Dizziness, Loss of consciousness, Nausea, Syncope
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female with osteopenia who on 11-JAN-2007 was vaccinated with Gardasil vaccine (yeast) (lot#655165/1425F), intramuscularly in the left arm. Concomitant therapy included FOSAMAX and calcium (unspecified). Subsequently, on 11JAN-2007, the patient "passed out", "fainted", was dizzy and nauseated. The patient recovered. There were relevant diagnostic or laboratory tests. It was noted that the patient had eaten before vaccination. Unspecified medical attention was sought. The reporter considered the patient's experience to be disabling because the patient was incapacitated for a short time. Additional information has been requested. FOSAMAX, calcium (unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Osteopenia NONE


Page 560
Days 0
State MA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Complicated migraine, Dyskinesia, Headache, Loss of consciousness, Myoclonic epilepsy, Oedema peripheral, Road traffic accident
Symptom Text: About 1-2 hrs after vaccination, while driving, lost consciousness, crashing into a car and mailboxes before regaining consciousness. 01/31/07-records received and reviewed. Neuro consult 1/17/07. Assessment:episodes of loss of consciousness. Differential diagnoses could include Juvenile Myoclonic Epilepsy, complicated migraine or cardiac arrhythmia. Holter monitor to evaluate for dysrhythmia. Psychotherapy with respect to her depression and medical management. PMH:This past summer had an episode where she suddenly got dizzy with the onset of sharp headache and then lost consciousness. She go back up and then blacked out again. No tongue biting or urinary incontinence. Disorientation lasted few minutes. Felt tired and achy but no further dizziness. In October 2006, episode of dizziness without loss of consciousness. Lips turned blue and whole body numb and tingling, greater on right side than left side. Head injury in October with concussion, confusion and dazed afterwards. EEG in October 2002 normal, MRI in March 2003 normal. On 1/15/07 while driving she was unaware that she had hit two mailboxes and a car. Half hour before accident she received HPV and noted swelling and throbbing at injection site. Experienced headache with this. Reports some occasional body jerks, especially noted at night when she is tired. PMH: depression, migraines which started in middle school, eczema, asthma and chicken pox. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE CT cervical spine:minor scoliosis convex left. 24 hour ambulatory EEG:No epileptiform activity or persistent focal asymmetries occurred. Depression, 1x syncope 06/06 migraines H/X nasal congestion


Page 561
Days 0
State TX
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Blood pressure decreased, Disorientation, Fall, Loss of consciousness
Symptom Text: Shortly after administration of vaccine, patient loss consciousness, fell from exam table to floor. Was out for 2-3 minutes, was very disoriented and seemed to have difficult time waking. Blood pressure was checked about 5 minutes later when move back to table. Had dropped from initial measurement of 100/70 to 80/40-patient rested for approximately 30 minutes and pressure went back up to 90/70. Patient allowed to leave. Patient has no history of any reactions to injections. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 562
Days 0
State MI
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pregnancy test positive, Ultrasound uterus, Vaginitis bacterial
Symptom Text: Information has been received from a physician through the pregnancy registry concerning a 17 year old female with episodic reflux and dyspepsia and no know drug allergies and no previous pregnancies who on 16-Oct-2006 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot3653735/0688F). Concomitant therapy included Prilosec OTC. From 20-Oct-2006 to 26-Oct-2006 the patient was placed on therapy with Flagyl 500 mg twice daily for bacterial vaginitis. On 31-Oct-2006 the patient was found to have a positive pregnancy test. LMP was 11-Sep-2006. Unspecified medical attention was sought and the patient was placed on prenatal vitamins. On 19-Dec-2006, an ultrasound revealed gestational age 24.7 weeks which was not consistent with the estimated date of LMP. No other symptoms were noted. At the time of this report, the outcome of the events was unknown. Additional information has been requested. PRILOSEC OTC mg Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ultrasound 12/19/06 - gest age 24.7 weeks, beta-human chorionic 10/31/06 - positive Pregnancy NOS (LMP = 9/11/2006), Gastroesophageal reflux, Dyspepsia


Page 563
Onset Date Unknown
Days
State CO
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Sneezing
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 ml of Gardasil vaccine (yeast). Subsequently, the patient sneezed consistently for 12 hours. The patient sought unspecified medical attention. It was reported that the patient recovered "12 hours after it started" (date unknown). Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 564
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a "nurse" via a company representative concerning an 18 year old female who, on an unspecified date, was vaccinated with a dose of Gardasil vaccine (yeast). The nurse reported that the patient experienced nausea and dizziness the same day as the vaccination, It was reported that the patient had "blood work" done (results not reported). It was not known whether the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory - "blood work" results not reported UNK


Page 565
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site erythema
Symptom Text: Information has been received from a physician concerning a 22 year old female who was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently, after receiving the vaccination, the patient developed red lesions around the injection site on her arm. On an unspecified date, the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 566
Days 0
State MD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Heart rate normal, Pallor, Syncope
Symptom Text: Information has been received from a registered nurse concerning a female patient who on 13-Dec-2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#654389/0961F). There was no concomitant medication. On 13-Dec-2006, shortly after vaccination the patient fainted and her skin color was pale. The patient was aroused by shaking her right arm and with smelling salts. The patient's vital signs were found to be normal upon discharge from the office. No further details were provided. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: vital sign 12/13/06 - normal UNK


Page 567
Days 1
State FL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Oedema peripheral
Symptom Text: Information has been received from a nurse at a physician's office concerning a female patient with a history of hepatitis C who on 11-Dec-2006 was vaccinated with Gardasil vaccine (yeast). On 12-Dec-2006 the patient reported that she had developed swelling of her hands. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Hepatitis C


Page 568
Days 7
State IL
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Infectious mononucleosis
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female patient with asthma, penicillin allergy, sulfonamide allergy and a history of infectious mononucleosis in December 2005, who on 21-Oct-2006 was vaccinated with the second dose of Gardasil vaccine (yeast) (lot# 654540/0800F). There was no concomitant medication. It was reported by the patient's mother that one week following vaccination, on approximately 28-Oct2006 the patient developed mononucleosis which had been confirmed by a blood test taken at the university the patient attended. Unspecified medical attention was sought, however the patient received no treatment. At the time of this report the patient had not yet recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: serum Epstein-Barr 10/28?/06 - positive Infectious mononucleosis, asthma, penicillin allergy, Sulfonamide allergy


Page 569
Days 1
State KY
Prev Doses
ER VISIT, NOT SERIOUS Breast swelling
Symptom Text: Information has been received from a physician concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 08-Dec2006 was vaccinated intramuscularly with Gardasil vaccine (yeast) (0.5 ml) (lot#653736/0868F). Concomitant vaccination given on an unspecified date included influenza virus vaccine (unspecified). Other concomitant medication included hormonal contraceptives (unspecified).On 09-Dec-2006, one day after receiving the Gardasil vaccine (yeast), the patient experienced breast swelling. It was reported that there was no significant pain, however the patient could not lie on her breast. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 570
Days 0
State MO
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthenia, Dizziness, Hypotension, Nausea
Symptom Text: Information has been received from a health professional concerning a female who on 12-Dec-2006 was vaccinated with what was thought to be the first dose of Gardasil vaccine (yeast). On 12-Dec-2006, following vaccination, the patient felt dizzy, weak, and nauseous and was noted to have a low blood pressure with a systolic of 100. The patient did not faint. The patient did not recover in the office and was therefore sent to the emergency room. She was not admitted. At the time of this report, the outcome of the events was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure - low UNK


Page 571
Days 4
State TX
Manufacturer MERCK & CO. INC. CHIRON CORPORATION
Prev Doses 0
ER VISIT, NOT SERIOUS Dizziness, Headache
Symptom Text: Information has been received from a physician concerning a 16 year old female who on approximately 27-Nov-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#653650/0641F). Concomitant vaccination the same day included Fluvirin vaccine. It was reported that " a few days after receiving the vaccination", on approximately 01-Dec-2006, the patient experienced dizziness when standing and walking and experienced a headache. Unspecified medical attention was sought. Subsequently, the patient recovered from the dizziness and headache on an unspecified date. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 572
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site irritation
Symptom Text: Information has been received from a consumer concerning her 11 year old daughter who on 26-Oct-2006 was vaccinated IM with "one shot" of Gardasil vaccine (yeast). The patient felt like it was burning. She is recovering on an unspecified therapy. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 573
Onset Date Unknown
Days
State MN
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pain, Injection site pain, Lymphadenopathy
Symptom Text: Information has been received from a pharmacist concerning her 13 year old daughter who in approximately October 2006 was vaccinated intramuscularly in the upper deltoid of left arm with the first dose if Gardasil vaccine (yeast). On an unspecified date, the patient developed lots of pain and tenderness in her arm around the injection site for a few days after receiving Gardasil vaccine (yeast). The pharmacist reported that her daughter developed three swollen and tender lymph nodes on her left side of her neck. The lymph nodes were really swollen for about three weeks and the tenderness lasted for about two weeks. The pharmacist was planning to have her daughter vaccinated again with the second of Gardasil vaccine (yeast) some time around 25-Dec-2006. At the time of this report, the patient had recovered from the events "about three weeks after the first dose". Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 574
Days 0
State MD
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Headache, Lymphadenopathy, Neck pain, Pyrexia
Symptom Text: Information has been received from a certified medical assistant concerning a 19 year old female with a mold allergy who on 13-Dec-2006 was vaccinated IM into the left deltoid with a 0.5 ml dose of Gardasil vaccine (yeast) (lot#654540/0800F). Concomitant therapy included Advair, Allegra, montelukast sodium, Ortho-Tri-Cyclen Lo and Lexapro. On 13-Dec-2006 the patient experienced a fever of 101.4 degrees F, head pain, neck pain and swollen glands. Her fever decreased to 99.1 degrees F. On 14-Dec-2006, she called the office to report these events. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. LEXAPRO ORTHO TRI CYCLEN LO ALLEGRA ADVAIR SINGULAIR Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: body temperature 12/13/06 101.4 degrees - fever body temperature 12/13/06 99.1 degrees Mycotic allergy


Page 575
Days 0
State VT
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female with no medical history or allergies, who on 30-Nov-2006 was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included an unspecified hormonal contraceptives (unspecified). On 30-Nov2006, the patient experienced severe injection site pain. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 576
Onset Date Unknown
Days
State VT
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history or allergies, who was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (unspecified). Subsequently, the patient experienced severe injection site pain at the time of immunization. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 577
Onset Date Unknown
Days
State NY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 22 year old female who on an unknown date was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently, the patient broke out with acne all over her face. Unspecified medical attention was sought. No diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 578
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Allergy to vaccine
Symptom Text: Information has been received from a physician concerning a female (age not reported) who was "positive for one strain of papilloma viral infection". On an unspecified date, the patient was vaccinated intramuscularly with the first "single dose vial" of Gardasil vaccine (yeast). Subsequently, the patient developed an "allergic reaction". The patient was sought unspecified medical attention. The patient was treated with a "steroid dose pack". At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Papilloma viral infection UNK


Page 579
Days 1
Received Date 22-Jan-2007 Lot NULL NULL
State MI
Prev Doses
ER VISIT, NOT SERIOUS Acne, Dry skin, Hypersensitivity, Rash pruritic
Symptom Text: Information has been received from the mother of a 14 year old female who on 27 Sep 2006 was vaccinated with a dose of Gardasil. Vaccination the same day included a dose of influenza virus vaccine (unspecified). Concomitant therapy included Allegra. On 28 Sep 2006, the next day, the patient developed little, itchy bumps on her legs and pimple like bumps on her back. The patient's mother reported that it may or may not have been an allergic reaction, or it "could have been" dry skin. The patient takes therapy with Allegra every day, although, the mother was unsure if the patient had taken it the day of the vaccination. Unspecified medical attention was sought. Subsequently, the patient fully recovered the same day. No other vaccinations have been given. Additional information has been requested. Allegra Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 580
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site haemorrhage
Symptom Text: Information has been received from a physician concerning a female who on 12 Dec 2006 was vaccinated with a "full" dose of Gardasil. At the time of administration, a small amount of bleeding was reported at the injection site. The bleeding was controlled prior to the patient leaving the physician's office on 12 Dec 2006. The patient called the office the day (13 Dec 2006) and reported that she had bled from the injection site and that the "blood had run down her arm". The patient feels that she did not get the full vaccination because of the bleeding problem. It was reported that the patient sought unspecified medical attention. As of 13 Dec 2006, the patient had recovered from bleeding at the injection site. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 581
Days 0
State TN
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site oedema, Smear cervix abnormal, Smear cervix normal, Vaginitis bacterial
Symptom Text: Information has been received from a nurse practitioner concerning a 19 year old female with an allergy to penicillin who on 21 Oct 2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot #653650/0702F). Concomitant therapy included hormonal contraceptives (unspecified). On 21 Oct 2006 the patient experienced minor redness and swelling at the injection site, which later resolved. On 08 Dec 2006 the patient presented with bacterial vaginosis and had a positive pap smear test for high risk HPV types. It was noted that on an unspecified date in November 2006 and on 09 Dec 2005 the patient's pap smear tests were negative. Subsequently, unspecified medical attention was sought and the patient had not recovered from positive pap smear test. Additional information has been requested. hormonal contraceptives Other Meds: cervical smear, 12/8/06, + High risk HPV types; cervical smear 11/04, negative; cervical smear 12/09/05, negative. Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 582
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Adverse drug reaction
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Subsequently, the patient developed an "adverse reaction". No details were given of the adverse experience. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 583
Onset Date Unknown
Days
State NC
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a Nurse Practitioner concerning a 15 year old female patient who was vaccinated with her first dose of Gardasil. Subsequently, the patient experienced prolonged dizziness. Medical attention was required. The patient recovered. The nurse practitioner reported that she was unsure if the 2nd dose of Gardasil should be administered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 584
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Laboratory test, Ophthalmological examination, Ophthalmological examination abnormal, Urine analysis
Symptom Text: Information has been received from a nurse practitioner concerning an 11 year old female with a history of Lyme disease, and ear infection, "reactive airways" and no known allergies or adverse drug reactions reported. On 01-Nov-2006, the patient was vaccinated intramuscularly with 0.5 ml of Gardasil vaccine (yeast). Subsequently, the patient developed dizziness for about three weeks. It was reported that the patient "had some lab studies done and was referred to a neurologist (she had not seen him yet). The laboratory diagnostics included blood sugar, a urinalysis and vision screening (results not reported). The nurse practitioner reported that there were some family issues that were occurring also be a cause. The patient was referred to an eye physician because she failed her school eye exam. At the time of this report, the patient was recovering from the events. Additional information has been requested. UNK Other Meds: diagnostic urinalysis ophthalmogical exam blood glucose Lab Data: History: Prex Illness: Prex Vax Illns: Lyme disease, Ear infection, Reactive airway disease


Page 585
Days 0
State FL
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (NOS) who on approximately 07-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Immediately after receiving the injection on approximately 07-Dec-2006 the patient developed hives in the same arm where she received the injection. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the hives. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 586
Days 0
State CO
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Rash generalised
Symptom Text: Information has been received from a physician concerning a 15 year old female with sulfonamide allergy who on 14-Dec-2006 was vaccinated with a first dose of Gardasil vaccine (yeast) (lot#653650/0697F) pre-filled syringe IM into the left deltoid. Concomitant vaccination on 14-Dec-2006 included a dose of influenza virus vaccine (unspecified) (manufacturer unknown). On 14-Dec-2006 the patient experienced broke out in rash all over her body. There was no fever associated with the rash. It was unclear if there was any local rash or reaction at the injection site. At the same visit the patient was given amoxicillin for an unknown reason. As of 15-Dec-2006 the rash persisted. Additional information has been requested. amoxicillin influenza virus vaccine Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE sulfonamide allergy


Page 587
Days 1
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Full blood count normal, Injection site pain, Red blood cell sedimentation rate normal
Symptom Text: Information has been received from a physician concerning a 20 year old female with an allergy to antibiotics who on 16-Nov-2006 was vaccinated with a first dose of Gardasil vaccine (yeast). On 17-Nov-2006 the patient developed pain at the injection site. The patient began to have joint pain throughout her body. The location of the joint rotated and was in her right knee at the time of this report. Laboratory evaluations revealed that erythrocyte sedimentation rate and complete blood count were normal. The patient was to be seen by a neurologist. The physician reported that she would most likely hold off on the second dose of Gardasil vaccine (yeast). At the time of this report, the patient's joint pain persisted. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: complete blood cell 11?/??/06 - normal erythrocyte 11?/??/06 - normal Allergic reaction to antibiotics


Page 588
Days 0
State TN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Headache, Nausea, Upper respiratory tract infection
Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female with gastric reflux who on 17-Oct-2006 was vaccinated IM with a first dose of Gardasil vaccine (yeast) (lot#653735/0688F). Concomitant therapy included Nuvaring and Aciphex. That evening the patient experienced quite a bit of nausea and a headache. It was noted that the patient couldn't study. On 18-Oct-2006, the nausea was gone. The patient thought that her headache was due to new contacts. On 19-Oct-2006, the patient's headache went away after she took her contacts out. One month later the patient experienced a upper respiratory infection but the nurse practitioner did not think it was related to the vaccine. Unspecified medical attention was sought. No diagnostic laboratory studies were involved. At the time of this report the outcome of upper respiratory infection was unknown. No product quality complaint was involved. Additional information has been requested. NUVARING ACIPHEX Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Gastroesophageal reflux


Page 589
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug hypersensitivity, Face oedema, Lip swelling, Myalgia
Symptom Text: Information has been received from a registered nurse concerning a 51 year old female with an allergy to benzoyl peroxide who on 11-Dec-2006 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast). Concomitant therapy included Yasmin. On 14-Dec-2006 the patient began to experience muscle aches, and on 17-Dec-2006 the patient began experiencing swelling of her face and lips, but no rash. The patient treated herself with Benadryl and was scheduled to see her physician on 18-Dec-2006. At the time of this report, the muscle aches and swelling of her face and lips persisted. Additional information has been requested. YASMIN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE HYPERSENSITIVITY


Page 590
Days 0
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 19 year old female with no persistent medical history or drug reactions/allergies, who on 15-Dec2006 was vaccinated with Gardasil vaccine (yeast) (0.5 ml0. There was no concomitant medication. On 15-Dec-2006, following, vaccination, the patient developed a red itchy rash "all over". Unspecified medication attention was sought. At the time of this report the patient had not recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory 12/??/06 - results not provided NONE


Page 591
Days 0
State SD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthenia, Dry skin, Dysgeusia, Feeling hot and cold, Influenza like illness, Nasopharyngitis, Nausea, Weight decreased, White blood cell count normal
Symptom Text: Information has been received from a physician and a registered nurse concerning a 27 year old female with narcolepsy and migraines and a history of cervical dysplasia and papilloma viral infection, and no known allergies, who on 14-Aug-2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil vaccine (yeast) (lot#653937/0637F). Concomitant therapy included "a medication for narcolepsy", Imitrex tablets, Excedrin Migraine, Aviane and dextroamphetamine. On 14-Aug-2006, following the vaccination, the patient experienced flu-like symptoms, nausea, hot and cold sensations, weight loss, decreased energy, cold respiratory symptom, dry skin, and a taste of iron in her mouth. On 04-Oct-2006, the patient was seen by her primary care physician and her white blood count was noted to be within normal range. The patient received the second dose of Gardasil vaccine (yeast) in the right deltoid on 20Oct-2006. On 14-Dec-2006 the patient called her physician's office and stated that she was experiencing the same type of flu-like symptoms and thought it was related to the vaccine. At the time of this report, the patient had not recovered . Unspecified medical attention was sought. The nurse reported that the patient missed work or school due to the symptoms, however the nurse did not feel the events were serious. It was recommended to the patient not to receive the third dose of Gardasil vaccine (yeast). Additional information has been requested. (therapy unspecified) EXCEDRIN MIGRAINE dextroamphetamine AVIANE IMITREX TABLETS Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: WBC count 10/04*06 - WNL Cervical dysplasia, Papilloma viral infection Narcolepsy, Migraine


Page 592
Onset Date Unknown
Days
State IN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Amenorrhoea
Symptom Text: Information has been received from a physician concerning a female patient (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 593
Days 2
State NM
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Headache
Symptom Text: Information has been received from a Nurse Practitioner concerning an 18 year old female who on 11 Dec 2006 was vaccinated with the first dose of Gardasil (yeast) (Lot # 653736/0868F). Concomitant therapy included hormonal contraceptives (unspecified). Within 48 hours post vaccination, on approximately 13 Dec 2006 the patient experienced a severe headache. The patient sought unspecified medical attention. The headache was treated with Tylenol and resolved "in one day". Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 594
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dyspnoea, Tachycardia
Symptom Text: Information has been received from a nurse concerning a 24 year old female with a history of panic attacks who on 07-Nov-2006 was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast) (lot#653938/0954F). Concomitant therapy included Asacol. On 07-Nov-2006 later that night, the patient experienced tachycardia and difficulty breathing. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product complaint was involved. Additional information has been requested. ASACOL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK PANIC ATTACK


Page 595
Days 0
State TX
Mfr Report Id WAES 0612USA03131 Route Intramuscular
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Drug administered at inappropriate site, Pain, Sciatic nerve injury, Sciatica
Symptom Text: SCIATICA; DRUG ADMINISTERED AT INAPPROPRIATE SITE. Information has been received from a nurse practitioner concerning a female patient who on 19-DEC-2006 was vaccinated IM into the dorsogluteal muscle with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medications. On 19-DEC-2006, the patient experienced sciatic nerve pain (noted that when the patient was vaccinated the sciatic nerve was hit). The pain went up her back and then it crossed over to the middle onto the left back. The pain occurred right after the injection. It was noted that there was no bruising or inflammation. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 596
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a clinical coordinator at a doctor's office concerning a female who was vaccinated with a first and second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently, the patient fainted after receiving both doses. The patient recovered. There were no relevant diagnostic test or laboratory data. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 597
Days 0
State --
Mfr Report Id WAES 0612USA03152 Route By Mouth
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Asthenia, Dizziness, Nausea
Symptom Text: Information has been received from a consumer concerning her 53 year old father with liver problems and no drug allergies who on 22-NOV-2006 inadvertently received HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml), orally. There was no concomitant medication. Subsequently, "in late November" the patient experienced nausea, dizziness and weakness. At the time of the report, the patient had not recovered. There were no relevant diagnostic tests or laboratory data. Additional information is not expected. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Liver disorder


Page 598
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pain, Pain in extremity
Symptom Text: Information has been received from a registered nurse concerning her 20 year old daughter with no medical history or allergies, who on 18-DEC-2006 was vaccinated IM with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. On 18-DEC-2006, the patient experienced throbbing pain in her arm. Unspecified medical attention was sought. No diagnostic studies were performed. At the time of this report, the patient's pain was subsiding. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 599
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from an office manager concerning a 17 year old female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL, injection. concomitant medication was not reported. Subsequently on an unspecified date, the patient fainted after she received the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sough unspecified medical attention. The office manager stated that the patient did not have anything to eat prior to receiving the injection. Subsequently on an unspecified date, the patient recovered from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 600
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash while being administered HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sough unspecified medical attention. The outcome of the event was not reported. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 601
Days 2
State NY
Site Unknown
ER VISIT, NOT SERIOUS Injection site pruritus
Symptom Text: Information has been received from a nurse concerning a 19 year old female patient with asthma, depression and allergies to valproate sodium, diazepam, gabapentin and acetaminophen (+) butalbital (+) caffeine who on 18-DEC-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLF vaccine (yeast), 1pt #654540/1161F. Concomitant therapy included montelukast sodium (MSD), escitalopram oxalate, lansoprazole, and metoprolol succinate. On 20-DEC2006 the patient called the office and stated that the injection site was itchy. Medical attention was sought. The physician's office to follow up with patient, her outcome was unknown. Additional information has been requested. Lexapro, Prevacid, Toprol XL tablets, Singulair Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Asthma; Depression; Drug hypersensitivity


Page 602
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Influenza like illness, Pain
Symptom Text: Initial and follow-up information has been received from a health professional concerning a 14 year old female who in "early" December 2006, was vaccinated with Gardasil. There was no concomitant medication. Subsequently in "early" December 2006, the patient experienced flu-like symptoms and pain for about 4 days after injection. The sought unspecified medical attention. No diagnostics were performed. Subsequently, in "mid-December" the patient recovered from flu-like symptoms and pain for about 4 days after injection. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 603
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a clinical manager concerning a female who on "13-DEC-2006 or 14-DEC-2006" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). On 13-DEC-2006, or 14-DEC-2006, the patient fainted almost immediately after receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 604
Days 0
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pain, Vaccination complication
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who in approximately December 2006, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). In approximately December 2006, when administering the vaccine with the prefilled syringe, the nurse release the spring before removing the syringe, therefore causing the patient pain at the injection site. No additional information was available at the time of reporting. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 605
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 22 year old female with pertinent medical history and drug reaction/allergies not reported who on an unspecified date was vaccinated with the initial dose of Gardasil injection. Concomitant medication was not reported. In December 2006 ( a few weeks ago), the patient fainted after Gardasil was administered. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 606
Days 0
State MD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Flushing, Hypotension, Malaise
Symptom Text: Information has been received from a licensed practical nurse concerning a 20 year old female who had hypersensitivity reported as "Motrin for allergies". On 19 Dec 2006, the patient was vaccinated intramuscularly with the firs "single dose vial" of Gardasil (Lot # 653938/0954F). Concomitant therapy included Motrin, Desogen, Allegra and Zantac. On 19 Dec 2006, "almost immediately after vaccination", the patient became a little flushed in the face and had to take a minute to sit and gather herself together. The patient was noted to have a blood pressure of 101/65 mmHg (date unknown). The patient sought unspecified medical attention. It was reported that the patient" improved within seconds". On 19 Dec 2006, the patient had recovered from the event. The licensed practical nurse reported that they were planning to vaccinate for the second and third dose as indicated in the "PI". Additional information has been requested. Desogen, Allegra, Motrin, Zantac Other Meds: blood pressure, 12/19/06, 101/6 mmHg Lab Data: History: Prex Illness: Prex Vax Illns: hypersensitivity


Page 607
Days 4
Received Date 22-Jan-2007 Lot 0641F 72222
State --
Manufacturer MERCK & CO. INC. CHIRON CORPORATION
Prev Doses
ER VISIT, NOT SERIOUS Dizziness postural, Headache
Symptom Text: Information has been received from a physician concerning an 18 year old white female who on 27 Nov 2006 was vaccinated with Gardasil (lot number 653650/0641F). Concomitant therapy on 27 Nov 2006 included Fluvirin. On 01 Dec 2006 the patient experienced dizziness with walking or standing. On 02 Dec 2006 the patient experienced headache on top of her head. Subsequently, the patient recovered from dizziness with walking or standing and headache on top of her head. A prescription treatment was given for the experiences (not specified). Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 608
Onset Date Unknown
Days
State OR
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Burning sensation, Pain
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently, following vaccination, the patient experienced pain and a burning sensation in the arm. Unspecified medical attention was sought. At the time of this report, the patient's pain and burning sensation in the arm persisted. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 609
Days 4
State NC
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Anogenital warts, Pain
Symptom Text: Information has been received from a pharmacist and a 25 year old female patient with sulfonamide allergy reporting that on 18 Dec 2006 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Lexapro. Four days later, on approximately 22 Dec 2006, the patient developed painful genital warts. The patient's painful genital warts persisted and she sought unspecified medical attention. Additional information has been requested. Lexapro Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: sulfonamide allergy


Page 610
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Herpes virus infection
Symptom Text: Information has been received from a certified medical assistant concerning a patient who on 25 Aug 2006 was vaccinated with a first dose of Gardasil, intramuscularly. Subsequently the patient developed a herpes virus infection. The patient's pediatrician had concluded that the infection was not due to Gardasil. It was also reported that the patient's second dose was delayed because some time after the first dose, because she developed the herpes virus infection. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 611
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Diarrhoea
Symptom Text: Information has been received from a female patient (age not reported) who on an unspecified date was vaccinated with the initial dose of Gardasil. Concomitant medication was not reported. In December 2006, the patient experienced really bad diarrhea after receiving the first dose of Gardasil. The outcome of the event was not reported. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 612
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Presyncope
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient almost fainted immediately after receiving Gardasil. The nurse at the physician's office stated that the girl seemed "afraid of needles." The outcome of the event was not reported. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 613
Onset Date Unknown
Days
State FL
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Diarrhoea, Lymphadenopathy, Nausea, Pharyngolaryngeal pain, Vomiting
Symptom Text: Information has been received from a physician via a company representative concerning a female (age not reported) who, on an unspecified date, was vaccinated with a first dose o Gardasil (Lot # not reported). The physician reporeted that after the first dose, the patient experienced nausea, diarrhea and vomiting. The physician also reported that after the second dose of Gardasil, the patient experienced a sore throat and swollen glands. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 614
Days 4
State IL
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash generalised
Symptom Text: Information has been received from a consumer concerning her 14 year old daughter who on 20 Dec 2006 was vaccinated with a first dose of Gardasil. On 24 Dec 2006, the patient developed a full body rash. The patient did not seek medical attention for her experience. At the time of this report, the patient had not recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 615
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a female pharmacist who was vaccinated IM with a second dose of Gardasil. The pharmacist reported that she did not feel the second injection. The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 616
Days 0
State FL
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on 22 Nov 2006 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 22 Nov 2006, the physician reported that the patient experienced reaction a "tendonitiis like" pain near the injection site. It was noted that there were no signs of cellulitis and the pain has not been responsive to OTC non-steroidal medication. At the time of this report, the patient had not recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 617
Days 3
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Contusion, Rash
Symptom Text: Information has been received from a 26 year old female pharmacist who on 27 Dec 2006 was vaccinated with a 0.5 mL dose of Gardasil. On 30 Dec 2006, the patient developed bumps on skin, located mainly on the back, sporadic on the chest, 5-6 noted, and also on belly: none on legs. The pharmacist reported that they were painful and "felt like bruises," The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 618
Days 0
State PA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Pain in extremity
Symptom Text: Information has been received from the mother of an 11 year old female with an allergy to Rondec and migraines who on 25 Oct 2006 was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included an unspecified migraine therapy. The mother reported that her daughter received the second dose of Gardasil approximately 35 days after receiving the first dose. The mother was informed by her physician that it was "okay" and that the patient did not have to restart the series. The mother also reported that following the second vaccination, on 30 Nov 2006, her daughter experienced pain in the arm in which she was vaccinated. Unspecified medical attention was sought. The patient subsequently recovered from the paid on an unspecified date. Additional information has been requested. therapy unspecified Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: hypersensitivity, migraine


Page 619
Days 0
State --
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Hypoaesthesia oral, Lip swelling
Symptom Text: Information has been received from a nurse practitioner concerning a 15 year old female who on 27 Dec 2006 was vaccinated with a first dose of Gardasil concomitantly with a dose of influenza virus vaccine (unspecified) using a different injection site. On 27 Dec 2006, approximately 2 hours after the vaccination, the patient experienced swelling and numbness in her lower lip. On approximately 29 Dec 2006, the patient recovered without treatment. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 620
Days 0
State NJ
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female who on approximately 27 Dec 2006 was vaccinated with a second dose of Gardasil. On approximately 27 Dec 2006 the patient developed swelling in the arm. The patient was treated with Benadryl. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 621
Days 1
State NJ
Prev Doses 1
Symptom Text: Information has been received from an office manager concerning a 16 year old female who on 04 Dec 2006 was vaccinated IM, into the left deltoid, with 0.5 ml second dose of Gardasil (lot #653736/0868F). On 05 Dec 2006 the patient developed an itchy rash on her arm. The patient was treated with Benadryl and the rash was gone the on the night of 05 Dec 2006. On 06 Dec 2006, the patient recovered. The office manger reported that there was no adverse reaction after the patient's first dose of Gardasil. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 622
Days 1
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician concerning a teenage female who on 04 Dec 2006 was vaccinated with the second dose of Gardasil (lot#653736/0868F), IM injection. Concomitant medication was not reported. On 05 Dec 2006, the patient developed a rash on her forearms. The physician reported that the patient was seen by another physician in the office, who prescirbed Benadryl to treat the rash. The outcome of the event was not reported. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 623
Days 0
State NJ
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Injection site pain, Injection site rash, Rash
Symptom Text: Information has been received from an RN concerning a 21 year old female patient who on 23 Oct 2006 was vaccinated IM with her first dose of Gardasil, lot #654540/1162F. On approximately 27 Dec 2006 the patient was vaccinated with her 2nd dose of Gardasil. On 27 Dec 2006 the patient developed a painful injection site after vaccination and also developed a red rash going up and then down her arm and around the injection site. She was given Benadryl and advised to keep an ice pack on it for the rest of the day. As of the report date the patient was recovering. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 624
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Anaphylactoid reaction
Symptom Text: Information has been received from a registered nurse via a company representative concerning a 19 year old female with a latex allergy, who on 28 Dec 2006 was vaccinated with a 0.5 mL dose of Gardasil. The nurse reported that on 28 Dec 2006, the patient experienced "a near anaphylactic reaction". The patient's status was not reported. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Latex allergy


Page 625
Days 60
State IL
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 15 year old female who on 20-Oct-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included Ortho Evra. On 19-Dec-2006 the patient was diagnosed with mononucleosis by her primary care physician. The patient sought unspecified medical attention. At the time of this report the patient's mononucleosis persisted. The reporter felt that the mononucleosis was not related to therapy with Gardasil vaccine (yeast). Additional information has been requested. ORTHO EVRA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 626
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 12 year old female who on 01-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided).On unspecified date in December, 2006, the patient separate two periods (dates not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 627
Onset Date Unknown
Days
State KY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pruritus, Injection site swelling
Symptom Text: Information has been received from a health professional concerning a 19 year old female with a hypersensitivity to "sepna" who on an unspecified date was vaccinated (at another unspecified physicians office) with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included naproxen sodium (Aleve) and ibuprofen. Subsequently, the patient reported that she experienced itching and swelling at the injection site which spread to her body. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. ibuprofen ALEVE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: HYPERSENSTIVITY


Page 628
Onset Date Unknown
Days
State MI
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Hepatitis acute, Liver function test abnormal
Symptom Text: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included Strattera and Concerta. Subsequently, the patient presented to the reporting physicians office for her second dose of Gardasil vaccine (yeast) and the patient's mother reported that the patient had been diagnosed with "acute immune hepatitis". The physician reported that the patient was asymptomatic, looked fine and was not sick. The physician did not give the second dose of the vaccine at that time based on the report from the mother. The physician reported that she is watching the patient's liver function tests which have progressively risen to 70. The reporting physician felt that the auto immune hepatitis was not related to therapy with Gardasil vaccine (yeast). Additional information has been requested. STRATTERA CONCERTA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: hepatic function tests 70 UNK


Page 629
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Allergy to vaccine
Symptom Text: Information has been received from an RN concerning a patient who has an allergic reaction after being vaccinated with a dose of Gardasil vaccine (yeast). The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 630
Days 0
State --
Prev Doses
NO CONDITIONS, NOT SERIOUS Injection site pain, Vaccination complication
Symptom Text: Information has been received from a registered nurse concerning a female who in approximately December 2006, was vaccinated with Gardasil vaccine (yeast). In approximately December 2006, when administering the vaccine with the pre-filled syringe, the nurse released the spring before removing the syringe, therefore causing the patient pain at the injection site. No additional information was available at the time of reporting. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 631
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine (yeast), 0.5 ml, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash while being administered Gardasil vaccine (yeast). The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 632
Onset Date Unknown
Days
State IN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 633
Days 0
State NY
Prev Doses 1
Site Unknown
ER VISIT, LIFE THREATENING, SERIOUS Blood test normal, Computerised tomogram normal, Convulsion, Fall, Fatigue, Loss of consciousness
Symptom Text: Information has been received from a health professional concerning a 16 year old female who on 11-NOV-2006 was vaccinated intramuscularly with 0.5 ml of the first dose of Gardasil vaccine (yeast) (lot#654510/0962F) and had no difficulties with the vaccine. On 13-JAN-2007 the patient was given her second dose of Gardasil vaccine (yeast) (lot# not provided). Within a few moments of receiving the vaccine the patient experienced a seizure, had a very brief loss of consciousness and fell to the floor. The patient was sent to the emergency room for evaluation. The patient was not admitted to the hospital. While in the emergency room she had a CT scan, chest-x-ray and unspecified blood work. The results of these tests were all negative. The patient was seen for a follow-up appointment by the physician on 16-JAN-2007. The patient reported that she was tired, however had not suffered any additional seizures. The patient was referred for a neurology consult. The physician considered the event to be life-threatening. At the time of this report the patient had not recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: chest x-ray 01/13/07 - normal, computed axial 01/13/07 - normal, electrocardiogram 01/13/07 - normal UNK


Page 634
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Arthralgia, Dermographism, Gait disturbance, Oedema peripheral, Oedema peripheral, Urticaria
Symptom Text: Information has been received from a physician concerning her 20 year old daughter who on 11-JAN-2007 was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast) (lot#653938/0954F). Concomitant therapy included Yasmin. On 11-JAN-2007, fifteen minutes after the vaccination, welts appeared on the patient's neck and spread all over the body. Dermatographia resulted all over the patient's body, her hands and feet were swollen, and she experienced arthritic pain in her joints. It was reported that the patient was not able to walk because of the pain. The patient was treated with Zyrtec, dexamethasone and hydroxyzine. Unspecified blood tests were performed (results not reported). At the time of this report, the patient was not recovered. Welts, dermatographia, peripheral swelling, arthritic-like joint pain and the patient's inability to walk were considered to be disabling events. Additional information has been requested. Yasmin Other Meds: diagnostic laboratory 01/11?/07 - results not reported Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 635
Days 0
State UT
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Headache, Injection site rash
Symptom Text: pt had a rash at the injection site, and had a severe headache Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE~~~0~In Patient NONE


Page 636
Vaers Id: 271273-1 Age Gender U 13.0 VAX Detail:
Onset Date Unknown
Days
State --
Type VARZOS HPV4
Prev Doses
ER VISIT, NOT SERIOUS No adverse effect, Wrong drug administered
Symptom Text: Information has been received from a health professional and a pharmacist concerning a 13 year old patient who on an unspecified date was vaccinated with a dose of Zostavax. Unspecified medical attention was sought. The patient was not experiencing any know symptoms. it was reported that the error was not a result of product confusion. The patient's vaccination history reported to include a first dose of varicella virus vaccine live on an unspecified date, but not a second dose of varicella virus vaccine live. There was no product quality complaint involved. No further information was available. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 637
Vaers Id: 271281-1 Age Gender U 20.0 VAX Detail:
Onset Date Unknown
Days
State --
Type VARZOS HPV4
Prev Doses
ER VISIT, NOT SERIOUS No adverse effect, Wrong drug administered
Symptom Text: Information has been received from a health professional and a pharmacist concerning a 20 year old patient who on an unspecified date was vaccinated with a dose of Zostavax vaccine instead Gardasil vaccine (yeast). Unspecified medical attention attention was sought. The patient was not experienced any known symptoms. It was reported that the error was not a result of product confusion. There was no record of the patient ever receiving Varicella virus vaccine live. There was no product quality complaint involved. No further information was available. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 638
Days 1
State KS
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Nausea
Symptom Text: Gardasil given 1/9/07. On 1/10/07 complained of lightheadedness, nausea. Ran fever 1/13, 1/14, 1/15. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seizure disorder NONE Tegretol, Ovcon 35


Page 639
Days 1
Received Date 26-Jan-2007 Lot 1144F C2689AA 1209F 1424F U2002AC
State AZ
Mfr Report Id Route Subcutaneously Intramuscular Intramuscular Intramuscular Intramuscular
Type VARCEL TDAP HEPA HPV4 MNQ
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC. MERCK & CO. INC. AVENTIS PASTEUR
Right arm Gluteous maxima Gluteous maxima
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site inflammation, Injection site irritation, Injection site vesicles
Symptom Text: Gardasil was given in office. Pt. reported only some irritation at site following the administration of vaccine. The following day she developed local erythema and sm. blister. She was seen again in the office on 1/25/07. Superficial blister/inflammation of approx. 0.5 x 1.5cm was noted. No cellulitis noted. Area was lt. pink in color. Advised pt. to keep area clean and dry, apply antibiotic oint. if desired. Only local treatment needed. No further treatment anticipated. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 640
Vaers Id: 271341-1 Age Gender F 1.3 VAX Detail: Type HPV4 DTAP
Days 0
Received Date 26-Jan-2007 Lot 0954F UNKNOWN
State TN
Prev Doses 1 1
NO CONDITIONS, NOT SERIOUS Wrong drug administered
Symptom Text: Patient was administered a vaccination of gardasil by accident instead of the scheduled comvax. It was administer on 1/25/06. It has been only one and no symptoms have been observed. Gardasil is approved for patients of 9 years to 26 years. No studies have been done for a patient of 15 months. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 641
Days 0
State KS
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Convulsion
Symptom Text: Information has been received from a health professional concerning a 22 year old female patient who on approximately 01-NOV-2006 was vaccinated with a first IM dose of Gardasil vaccine (yeast). On approximately 01-NOV-2006 the patient experienced seizure. The reporter had no further information. It was noted that patient was 2 weeks late for her second dose of Gardasil vaccine (yeast) and had not yet received it. Upon internal review, seizure is considered an other important medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 642
Vaers Id: 271366-1 (S) Age Gender Vaccine Date U 10-Nov-2006 Unknown VAX Detail: Type HPV4
Days 1
State CT
Prev Doses
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Condition aggravated, Crohn's disease
Symptom Text: Information has been received from a physician concerning a patient (age and gender unknown) with Crohn's disease who on 10-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine (yeast) (Lot # 653978/0955F). On 11-NOV-2006 the patient had a flair up of Crohn's disease after receiving the Gardasil vaccine (yeast). The flair up was so severe that the patient had to be out of school for a month. The patient sought unspecified medical attention. No product quality complaint was involved. At the time of this report, the patient was recovering. The flair up of Crohn's disease was considered to be disabling. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Crohn's disease


Page 643
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age unspecified) with unspecified history of drug reaction/allergies and no pertinent medical history who on an unspecified date was vaccinated with Gardasil vaccine (yeast) (lot# not reported) 0.5 ml by injection. Concomitant therapy was not reported. Subsequently, the patient experienced a seizure after the injection of Gardasil vaccine (yeast). Medical attention was sought. At the time of reporting, the patient had recovered. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 644
Days 2
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female who on 11-Jan-2007 was vaccinated with Gardasil vaccine (yeast), intramuscularly. Concomitant therapy included Allegra and Nuvaring. On 13-Jan-2007 the patient had a "rash from her neck down". The patient was seen in the emergency room and was given Prednisone. At the time of the report, the patient was recovering. The reporter was considering giving the patient Benadryl and Prednisone before the next vaccination with Gardasil vaccine (yeast). The patient's experience was considered to be an other medical event. Additional information has been requested. NUVARING, ALLEGRA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 645
Vaers Id: 271369-1 Age Gender F Unknown VAX Detail: Type TDAP HEPA HPV4 Seriousness: MedDRA PT
Days 0
Received Date 29-Jan-2007 Lot NULL NULL NULL 0
State NJ
Manufacturer GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER MERCK & CO. INC.
Prev Doses
NO CONDITIONS, NOT SERIOUS Convulsion, Loss of consciousness
Symptom Text: Information has been received from a Registered Nurse concerning a female patient (demographics not reported) who on 10-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (lot # not provided). Concomitant therapy included BOOSTRIX and hepatitis A virus vaccine (manufacturer unknown). On 10-JAN-2007 immediately post vaccination the patient "passed out and went into a seizure." The patient sought unspecified medical attention. At the time of this report it was not reported if the patient had recovered from her experience. Upon internal review the seizure was considered to be an other medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 646
Days 0
State DE
Prev Doses 0
Symptom Text: Patient got dizzy, passed out. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 647
Days 2
State RI
Last Edit Date 09-Mar-2007 Other Vaccine HPV4
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Grand mal convulsion, Postictal state, Syncope
Symptom Text: 48 hours post injection-appeared to have witnessed tonic clonic seizures with postictal phase lasting less than 1 min. 03/01/07-records received from facility for DOS 01/12/2007-DX fainting. 03/01/07-records received from facility for DOS 01/12/2007-DX fainting. Singulair Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Ct- Brain Nec Labs received 3/1/07-strep screen negative for group A strep. CBC WNL except for lymphocyte 21.6. CT cranial-no intracranial abnormality. Some evidence her for mild paranasal sinus disease particularly on the left side seasonal allergies, asthma NONE


Page 648
Vaers Id: 271456-1 Age Gender F 14.0 VAX Detail: Type TDAP HEPA HPV4 Seriousness: MedDRA PT
Days 2
Received Date 29-Jan-2007 Lot C2638AA 0694F 0954F
Status Date 01-Feb-2007 Site Left arm Left arm
State MO
Prev Doses 0 0 0
Right arm
ER VISIT, NOT SERIOUS Injection site erythema, Injection site oedema
Symptom Text: Mild erythema and edema to Left deltoid. Prescribed over the counter Motrin 400 mg every 6-8 hours as needed. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 649
Onset Date Unknown
Days
Received Date 30-Jan-2007 Lot U2209AA U2310AA 0868F
State CA
Prev Doses 0 1 0
Site Right arm Left arm Right arm
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site swelling
Symptom Text: Child attended Karate class and instructor was tapping the injection not knowing that the child had received immunizations the day before. Red swollen the size of a baseball at site of injection on right deltoid. Area was tender to touch. None Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: eczema no allergies noted Seeing provider for eczema


Page 650
Days 4
State MO
Prev Doses 1
ER VISIT, NOT SERIOUS Confusional state, Disorientation, Feeling abnormal
Symptom Text: Awoke from nap on 01/21/2007 and was disoriented and confused. Taken to the ER where multiple tests were performed. This last several hours. Psychiatry was consulted as well. Patient states she felt funny the next day, but was ok by 01/23/2007. Lexapro Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CBC, chemistry profile, thyroid tests, drug screen, head CT, EEG - all tests were NORMAL Depression none


Page 651
Days 3
Received Date 31-Jan-2007 Lot 0011U
State CA
Prev Doses 0
Site Right arm
Symptom Text: I began to itch 3 days after my vaccination shot. At first, I thought it was my eczema acting up, but then I began to itch and scratch all over my arms, underarms, legs, and on my hip bones. Hives have appeared on these areas. i applied flucinonide on the itchy areas, but they still remain itchy. I will see the doctor tomorrow, but I do not believe I can see the doctor who recommended the vaccination. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: I have seasonal allergies, as well as allergies to animals, dust, plants, grasses, and trees. none


Page 652
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse (also reported as a physician) concerning a female who was vaccinated with her first dose of Gardasil vaccine (yeast) 0.5 ml. Subsequently the patient had a seizure. Subsequently, the patient recovered from the seizure. Therapy with Gardasil vaccine (yeast) will not be reintroduced. Upon internal review, seizure was considered an other important medical event. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 653
Days 0
State NC
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Chest pain, Hypersensitivity, Oxygen saturation normal
Symptom Text: Information has been received from a LPN concerning a 17 year old female with asthma who on 16-JAN-2007 was vaccinated with a first dose of Gardasil vaccine (yeast). On 16-JAN-2007 the patient experienced burning in her chest and lungs. The patient was seen at an Urgent Care facility and her lungs were found to be clear and her oxygen saturation was within normal limits. The Urgent Care physician's impression was that the patient experienced some type of allergic reaction. The patient was treated with Tylenol and Benadryl and instructed to come back if the symptoms did not improve or if they exacerbated. The LPN felt that there was a possibility of hospitalization at the time, however, at the time of this report, the patient was recovering and improving on treatment. No product quality complaint was involved. The reporter felt that allergic reaction was an other important medical event. Additional information has been requested. UNK Other Meds: pulse oximetry-within normal limits Lab Data: History: Prex Illness: Prex Vax Illns: ASTHMA


Page 654
Days 0
Status Date 01-Feb-2007 Site Left arm
State MA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Presyncope
Symptom Text: After receiving vaccine and getting off table felt dizzy walked to appointment desk and became very "oozy" almost fainted mom caught her put in trendelenberg position, given orange juice quickly felt better. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 655
Days 8
State MI
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Erythema, Pruritus, Rash, Urticaria
Symptom Text: One week after the injection,my daughter broke out with big hives,rash and itching. She was put on predizone.That did not sseem to help very much. It is a little over a month and she is better but still breaks out with red bumps and hives. allegra Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: allergic to peanuts none


Page 656
Days 8
Received Date 31-Jan-2007 Lot 1046F 1427F
State PA
Type VARCEL HPV4
Prev Doses 1 0
NO CONDITIONS, NOT SERIOUS Pruritus, Rash vesicular
Symptom Text: Started with signs of chicken pox 8 days after vaccine over entire back, neck, front, abdomen. No comitant symptoms no fever, no stomach symptoms, no pain, no cough, no runny nose, no sore throat. Positive puritis. Asmarx, Albuterol, Florim cream Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Eczema, Asthma NONE


Page 657
Days 18
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash erythematous, Rash pruritic
Symptom Text: On 1/4/2007, pt was given first dose of Gardasil vaccine. Also, on that day, changed OCP from Lo-ovral to Ovcon-35 because of spotting. Presnted 1/22/07 with pruitic rash consisting of tine erythematous papules on arms/legs/trunk Ovcon-35 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 658
Days 0
State MD
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Abortion induced, Drug exposure during pregnancy, Drug exposure during pregnancy, Pregnancy, Pregnancy test positive, Ultrasound scan
Symptom Text: Initial and follow up information has been received from a health professional concerning a 20 year old female patient with a history of 2 therapeutic abortions (2000 and 2004) abdominal pain, mild rectal bleeding, papilloma viral infection and sexually transmitted disease who on 08-JAN-2007 was vaccinated IM into the left deltoid with a second 0.5 ml of Gardasil vaccine (yeast) (lot#655619/1427F). Concomitant therapy included Risperdal and Celexa. The patient was reportedly pregnant at this time and did not tell the office. An HCG pregnancy test was done. The patient is scheduled for a prenatal visit on 19-JAN-2007. Her LMP was approximately 11-OCT-2006 and EDD 19-JUL-2007. An ultrasound on 18-JAN-2007 for gestational dates revealed of 7 weeks of 7 weeks and 3 days. The patient had an elective termination on 23-JAN-2007. There was no further information available. The patient received a first 0.5 ml dose of Gardasil vaccine (yeast) (lot#654540/0800F) on 23-OCT-2006 IM into the left deltoid. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested. Celexa, Risperdal Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ultrasound 01/18/2007 - 7 week 3 day gestational dates urine beta-human 01/08?/07 Abdominal pain, Rectal bleeding, Papilloma viral infection, Sexually transmitted disease, Termination of pregnancy elective.


Page 659
Days 1
State MA
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Pruritus, Rash, Rash, Rash, Rash, Swelling, Urticaria
Symptom Text: itching, swelling and hivelike rash with bumps on face the 1st day. next day, rash over face, neck, chest, upper arms. worse with exposure to cold air. resolved after warming about 15-20 min 1st day. 2nd day resolved with benadryl 25mg x 1. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 660
Days 0
State --
Mfr Report Id Route Subcutaneously
Prev Doses
Site Unknown
PERMANENT DISABILITY, SERIOUS Dizziness, Erythema, Nausea, Oedema peripheral, Pain in extremity
Symptom Text: Patient received 1st dose of Gardasil vaccine and the next day her arm got red and swollen and she experienced nausea and dizziness. 4 days later she reports arm continued to swell and be painful, but denies fever or chills. Patient was advised to take dihenhydramine and use ice on the area. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 661
Days 1
Received Date 02-Feb-2007 Lot 1424F 1210F
State NY
Prev Doses 0 0
ER VISIT, NOT SERIOUS Abdominal pain upper, Headache, Malaise, Pruritus, Rash generalised, Sneezing, Throat irritation
Symptom Text: Very severe skin rash covering the entire body. Itchy skin, some sneezing scratchy throat. Headache, stomach ache overall feeling of being unwell. After 4 days rash not gone. Treatment: Benadryl every 5 hours, Aveeno baths. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 662
Days 5
State MA
Prev Doses
Site Right arm
Symptom Text: 5 days after being administered the 2nd in a series of Gardasil developed hives requiring Benadryl and a visit to local ER. No facial edema, difficulty breathing or SOB occurred Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 663
Days 6
Received Date 02-Feb-2007 Lot 61784AA 0960F
State SD
Prev Doses 0 0
ER VISIT, NOT SERIOUS Abdominal pain, Aphthous stomatitis, Malaise, Pain, Pain, Pharyngolaryngeal pain
Symptom Text: Canker type sores in mouth still present. Complained of sore throat,achy,abdominal pain, general malaise the past couple of days but feeling better yesterday. Important to note is that she has a boyfriend who may have been infected with HG (herpes gladitorium)-his wrestling team had "ringworm" and "staph" and now area wrestlers are showing up with HG which is said to be confused often times with staph skin infections. Cold sores are common with HG and are contagious of course, so it might be possible that she contracted the sores by kissing her boyfriend who may have been infected with HG?? Not sure and can't prove that he was infected. Adderal and Seroquel Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Started not feeling well 1/30/07 pm. Stayed home the next day (1/31/07)due to above listed complaints. That evening she developed bad stomach pain. Taken to ER to rule out appendicitis-felt much better the next day but then began developing good physical health none


Page 664
Onset Date 02-Feb-2007
Days 4
Received Date 05-Feb-2007
State RI
Lot Prev Doses 0011UEXP21MA 0 R09
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash pruritic, Urticaria
Symptom Text: Patient complained of itchy rash on legs/arms for 3-4 days. She presented 2 days after the shot with raised hives on legs, feet and hands. She was placed on Medrol dose pack, Atarax, 100 1 qd Fluoxetine, Zometa, Trisprintec Other Meds: Allergic reaction, unspecified Lab Data: History: Prex Illness: Prex Vax Illns: Depression, No prior allergies NONE


Page 665
Days 0
State MI
Last Edit Date 06-Feb-2007 Other Vaccine TD
Prev Doses 0
Symptom Text: Patient suffered a vasovagal (syncope) reaction after vaccine given. Sent to ER Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE EKG-ne NONE NONE


Page 666
Onset Date Unknown
Days
Received Date 06-Feb-2007 Lot U2158AA 1447F
State MA
Prev Doses 0 0
ER VISIT, NOT SERIOUS Musculoskeletal pain, Pain in extremity
Symptom Text: 2 days after giving Menactra and HPV vaccine #1, pt developed L shoulder and L arm pain, with ok strength but pain with motion. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 667
Vaers Id: 271892-1 Age Gender F 12.0 VAX Detail: Type MNQ HEPA HPV4 Seriousness: MedDRA PT
Vaccine Date 05-Feb-2007
Days 0
Received Date 07-Feb-2007 Lot U2157BA 1280F 00144
State OH
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Fatigue, Feeling abnormal, Loss of consciousness, Vomiting
Symptom Text: Pt was receiving Gardasil, Hep A and Then Menactra. Right after administering the Menactra she said I feel funny and passed out. She was out for about 10 seconds. Then vomited 1x. Said she felt really tired. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 668
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Aphasia, Blood electrolytes normal, C-reactive protein normal, Chills, Computerised tomogram normal, Full blood count normal, Pharyngolaryngeal pain, Pyrexia
Symptom Text: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no history of drug reactions/allergies who on 26-JAN-2007 was vaccinated with Gardasil vaccine (yeast) (lot# not reported), IM. There was no concomitant medication. On 26-JAN-2007, the patient developed a sore throat, fever, and chills later that evening. She went to the emergency room on 30-JAN-2007 where she exhibited expressive aphasia. A computed tomography (CT) scan showed nothing. She was admitted to the hospital where she a neurology consult. All tests have come up negative (CT scan, magnetic resonance imaging, complete blood count, electrolytes, and C-reactive protein). The physician stated that the patient has 3 chinchilla pets and one of them has a fungal infection which is currently being treated with myconazole spray. The physician consulted the veterinarian as well as an infectious disease specialist. The physician saw the patient today and she was able to form some sentences. The physician is observing the patient and will order some additional tests. The physician reported the event will be a disability if this adverse event continues. Additional information has been requested. NONE Other Meds: computed axial 01/30/07 - negative, magnetic resonance 01/30/07 - negative, complete blood cell 01/30/07 - negative, serum c-reactive 01/30/07 - negative, Lab Data: serum electrolytes test 01/30/07 - negative, temperature measurement 01/30/07 - fever NONE History: Prex Illness: Prex Vax Illns:


Page 669
Vaers Id: 271904-1 (S) Age Gender Vaccine Date F 04-Jan-2007 12.0 VAX Detail: Type MNQ HPV4
Days 12
Received Date 07-Feb-2007 Lot U2091AA DPHVA017A
State --
Prev Doses
HOSPITALIZED, SERIOUS Chest X-ray normal, Erythema multiforme, Genital pruritus female, Lip swelling, Pneumonia, Pyrexia, Rales, Rash, Urine analysis normal
Symptom Text: Initial report received on 26 January 2007, from another manufacturer, under the reference number B0454855A, concerning a patient. A 12 year old female patient, was enrolled in the other manufacturers study and received on 04 January 2007 a dose of Menactra (lot number U2091AA) intramuscular intro the left upper deltoid and the first dose of study vaccine of Gardasil (lot number DHPVA017A). Since 16 January 2007, since 12 days post administration, the patient had been experiencing pneumonia and developed erythema multiforme and was hospitalized. The patient had been to th e(study) office two days prior to admission with fever, swollen lips and vaginal itch. Exam failed to reveal significant findings other than rales over left posterior lung fields (urine analysis and chest X ray were normal). A clinical diagnosis of rash fitting description of erythema multiform was made. The patient was discharged with symptomatic treatment. She was seen in emergency room the next day and admitted on 18 January 2007 for intravenous treatment (rochepin). The event was unresolved at the time of reporting. The other manufacturer's investigator considered that there was a reasonable possibility that th erythema multiforme may have been caused by Gardasil and Menactra and was due to pneumonia. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 670
Onset Date Unknown
Days
Received Date 07-Feb-2007 Lot UE552AA 0960F U22522A
State AZ
Prev Doses 0 0 0
Right arm
NO CONDITIONS, NOT SERIOUS Blood glucose normal, Blood pressure normal, Convulsion, Electrocardiogram normal, Syncope vasovagal
Symptom Text: Patient had a vasovagal syncopal episode with seizure seconds after receiving the vaccine. Checked blood sugar and BP and EKG and everything looked normal. Observed patient in clinic and no problems after. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: EKG, Blood sugar NONE NONE


Page 671
Vaers Id: 271956-1 Age Gender F 23.0 VAX Detail: Type HPV
Related reports: 271956-2 Vaccine Date Onset Date 23-Jan-2007 24-Jan-2007
Days 1
State MA
Manufacturer UNKNOWN MANUFACTURER
Prev Doses 1
ER VISIT, NOT SERIOUS Headache, Nausea
Symptom Text: headache and nausea different than usual migraine for 2 wks beginning day after Gardasil vaccine administration Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: migraines, eczema, condyloma, herpes simplex, lactose intolerance Mircette, Claritin prn, Imitrex, Naprosyn, Valtrex


Page 672
Related reports: 271956-1 Vaccine Date Onset Date 23-Jan-2007 24-Jan-2007 Manufacturer MERCK & CO. INC.
Days 1
State MA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Headache, Nausea, Sinusitis
Symptom Text: Information has been received from a certified medical assistant concerning a 23 year old female with migraine headaches who on 23-JAN-2007 was vaccinated IM with a second 0.5ml dose of Gardasil (lot #655205/1426F). The next day, the patient experienced headache and rated it 5 out of 10 on a pain scale. The patient took EXCEDRIN, EXCEDRINE MIGRAINE, TYLENOL, ALEVE, and IMITREX which did not relieve her headache. Her headache was constant. The patient also complained of nausea. On 08-FEB-2007, the patient was seen by her physician and was prescribed a Z pack and MUCINEX D for sinusitis. At the time of this report, the patient had not recovered. It was also reported that on 14-NOV-2006 the patient was vaccinated with a first dose of Gardasil. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Migraine


Page 673
Days 5
Received Date 09-Feb-2007 Lot V1974AM 1425F
State NJ
Prev Doses
ER VISIT, NOT SERIOUS Abnormal sleep-related event, Dyskinesia, Tremor, Tremor
Symptom Text: Gardasil and Menactra given 1/11/07 beginning 1/22/07 jerking, tremors, shaking episodes occurring only during sleep Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: EEG, CBC, SMAC, chest x-ray and barium swallow NONE NONE


Page 674
Onset Date Unknown
Days
State IL
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Computerised tomogram abnormal, Dizziness, Dizziness, Nausea, Vertigo
Symptom Text: Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast). The day after vaccination, the patient felt dizzy and lightheaded and experienced nausea. The patient was admitted to the hospital for 2 days. A CT scan performed at the hospital revealed vertigo. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: computed axial - vertigo UNK


Page 675
Days 1
State CA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral, Petechiae
Symptom Text: 14 y/o girl had distal swelling of both hands with erythema and some petechiae within one day of receiving 1st dose of gardasil. No other symptoms. Mother gave benadryl Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 676
Days 0
Received Date 09-Feb-2007 Lot 0012U
State TX
Prev Doses 0
ER VISIT, NOT SERIOUS Dizziness, Dizziness, Dyspnoea, Headache, Heart rate increased
Symptom Text: Headachem dizziness, increased heart rate, light-headness, shortness of breath. Symptoms began approximately 40 minutes after vaccination. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE blood glucose 86 mg/dl, temperature 97.1, pulse 88 and regular, BP 110/76 SpO2 99% ASTHMA NONE per patient


Page 677
Days 0
State CA
Prev Doses 1
Site Right arm
Symptom Text: R arm sore at injection site Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 678
Days 4
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Haematoma, Injection site cellulitis, Injection site erythema, Injection site haematoma, Injection site induration, Injection site pain, Injection site pain
Symptom Text: Information has been received from a physician concerning her daughter, a 19 year old female who on 13-OCT-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot#653938/0954F) without any difficulties. On 02-JAN-2007 the patient received the second dose of Gardasil vaccine (yeast) (lot#654389/0961F). Concomitant therapy included fluoxetine HCl (SARAFEM) and "Femcon" (NOS). On approximately 06-JAN-2007 the patient developed a tender reddened firm area in her upper arm around the injection site that "hurt her to sleep on". On an unspecified date the patient went to the emergency room and was diagnosed with cellulitis and treated with Cephalexin (Keflex). After 10 days of treatment with cephalexin was completed the patient's "reddened firm area went down and was less tender". However, with 48 hours of stopping the therapy with cephalexin the area was "reddened, firm and tender". After 5 days the patient was seen at her university health services office, who "refused to treat her for cellulitis and referred her back to her gynecologist who gave her the vaccine". On approximately 01-FEB-2007 the patient was then seen by the internist who diagnosed her with a hematoma. At the time of this report the cellulitis was considered resolved and the hematoma was resolving. The physician reported that the patient will continue with the third vaccination in her other arm. The reporting physician consider the cellulitis to be a serious other medical event. Additional information has been requested. Sarafem, Hormonal contraceptives. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 679
Days 1
State NY
Prev Doses
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Lethargy, Nausea, Rash pruritic
Symptom Text: Information has been received from a registered nurse concerning her 11 year old daughter with asthma, penicillin allergy and drug hypersensitivity to cephalexin (KEFLEX) who on 25-JAN-2007 was vaccinated with a dose of Gardasil vaccine (yeast). Concomitant therapy included lansoprazole (PREVACID), triamcinolone acetonide (NASACORT) and diphenhydramine HCl (BENADRYL). On 26-JAN-2007 the patient developed nausea, lethargy and a rash with pruritus on back. Unspecified medical attention was sought. There was no laboratory or diagnostic tests performed. At the time of the report, the patient was recovering. The registered nurse considered nausea, lethargy and pruritic rash to be disabling events. Additional information has been requested. Benadryl, Prevacid, Nasacort Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Asthma, Penicillin allergy, Drug Hypersensitivity


Page 680
Days 3
State UT
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fatigue, Injection site pain, Pruritus, Urticaria
Symptom Text: Information has been received from a Nurse Practitioner concerning a 19 year old white female who on 25-JAN-2007 was vaccinated intramuscularly with Gardasil (lot number not provided). On 28-JAN-2007 the patient experienced injection site pain and fatigue and developed pruritus and hives on her whole body. The patient was seen on an unspecified date by her primary care physician (contact information not provided) and treated with Vistaril 50 mg, PO every 6 hours and "comfort measures". On an unspecified date the patient was considered to have recovered from the hives, injection site pain and fatigue. The reporter considered the pruritus and hives to be serious other medical events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 681
Days 8
State PA
Prev Doses 0
ER VISIT, NOT SERIOUS Dizziness, Headache, Somnolence, Tremor
Symptom Text: Mother reported that on 1/12/07 patient was found in dorm room shaking rapidly, unarousable for several minutes, dizzy when she did awaken and complain of headache next day. College infirmary said normal BP and neuro status intact. Patient denies use of any alcohol or drugs. NONE? Fluticasone? Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE - no testing performed by school NKA NONE


Page 682
Days 1
Received Date 12-Feb-2007 Lot 00110
State KS
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Headache, Nausea, Pyrexia, Vomiting
Symptom Text: Headache, nausea, vomiting, subjective fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seasonal allergies NONE ZYRTEC, oral contraceptive pill


Page 683
Days 1
Received Date 16-Mar-2007 Lot 0011U
State KS
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Headache, Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a physician concerning a 15 year old female student with seasonal allergies who on 25-JAN-2007 at 3:00 Pm was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (lot #654702/0011U). There were no illnesses at time of vaccination. Concomitant therapy included hormonal contraceptives (unspecified). It was reported that on 26-JAN-2007, at 4:30AM, the patient experienced subjective fever, nausea, vomiting and headache. It was reported that the patient was unable to attend school for five days. The patient subsequently recovered from the events on 03FEB-2007. No further information is expected. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seasonal allergy NONE


Page 684
Vaers Id: 272155-1 Age Gender F 26.0 VAX Detail: Type TD HPV4
Days 1
Received Date 12-Feb-2007 Lot U1704DA 0960F
State MD
Prev Doses
Site Right arm Right arm
ER VISIT, NOT SERIOUS Erythema, Injection site induration, Injection site pain, Injection site pain
Symptom Text: 5cm tender induration at site (R biceps) with redness extending entire fore arm and pain at site of injection (Gardasil). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Required ER TX plus 2 additional MD office visits RX Prednisone.


Page 685
Onset Date Unknown
Days
State CA
Type TYP SMALL HPV4
Manufacturer Lot AVENTIS PASTEUR 205722 WYETH PHARMACEUTICALS, INC 4020076 MERCK & CO. INC. 1424F
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Pregnancy test negative, Pregnancy test positive
Symptom Text: Pt had negative pregnancy test 1/3/07, given smallpox vaccine and HPV. Had positive pregnancy test 1/27/07. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 686
Onset Date Unknown
Days
State TN
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Injection site induration, Injection site pain, Nerve injury
Symptom Text: Knot on arm after x 2 days, nerve damage, pain at site. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Metformin CT Scan PCOS


Page 687
Days 9
State VA
Prev Doses 1
ER VISIT, NOT SERIOUS Paralysis
Symptom Text: Episodes of transient paralysis. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 688
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Hypokinesia, Pain in extremity
Symptom Text: Information has been received from a physician concerning a 20 year old female with a penicillin allergy and no other reported health history who on 21-DEC2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) (0.5 ml), intramuscularly. Concomitant therapy included birth control pills. Subsequently, she had experienced severe pain in the arm since the vaccination. She was unable to raise her arm more than a 45 degree angle. She had been seen by her family physician who diagnosed her with "Frozen Arm Syndrome". it was reported that she would be seen by an orthopedic surgeon in a few days. It was noted that the patient is "thin build, weighed 119 pounds and was five feet six inches tall. It was noted that there was no previous injury to area or to arm. Unspecified medical attention was sought. At the time of the report, the patient was considered to be not recovered. The patient's experiences were considered to be disabling. Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Penicillin allergy


Page 689
Days 61
State PA
Prev Doses 0
Site Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS Blood glucose increased, Diabetes mellitus, Pollakiuria, Thirst
Symptom Text: Information has been received from a physician and the mother of a 12 year old female who in November 2006, was vaccinated intramuscularly with the first dose of Gardasil. It was reported that the patient returned to the physician's office to receive her second dose of Gardasil and the patient's mother mentioned to the physician that her daughter had recently complained of always being thirsty, frequent urination and her blood sugar was noted as 674. In January 2007, the patient was diagnosed with diabetes and was hospitalized. The patient was in the hospital for several days and was released (date unknown). At the time of this report, the outcome of the event was unknown. It was unknown if the patient received her second dose of Gardasil. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood glucose 674 UNK UNK


Page 690
Days 0
State NY
Lot Prev Doses 0011U AHAVB115BA
ER VISIT, NOT SERIOUS Blood pressure decreased, Fall, Head injury, Loss of consciousness, Tremor
Symptom Text: Approx 2-5 minutes after receiving vaccines patient passed out while getting dressed. There was no witness to the event. Patient lost consciousness and fell from the seated position hitting head in 3 places. Blood pressure had dropped. Patient had a short episode of tremors during the recovery phase. Patient was allowed to rest and rehydrate until blood pressure returned to normal (100/80) 30 minutes later. NONE Other Meds: Brain/C spin CT negative. Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to Ceclor NONE


Page 691
Days 1
State FL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Malaise, Pruritus
Symptom Text: Pruritis, Malaise Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sulfa allergy, headaches, overweight, Metrol/ Menorrhagia. Ibuprofen PRN


Page 692
Days 0
Received Date 14-Feb-2007 Lot 08005 1213R
State MD
Prev Doses 0 1
NO CONDITIONS, NOT SERIOUS Malaise, Nausea, Vomiting
Symptom Text: On 11/7/2006, Patient was administered Hepatitis B vaccine (dose #2) and Gardasil (dose #1), and developed severe nausea and vomiting approximately 12 hours later, lasting for approximately 1 hour. Patient felt ill the following day, then recovered. No rash, no fevers. No other reactions. No prior reactions to HepB vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none


Page 693
Days 0
State MD
Last Edit Date 15-Feb-2007 Other Vaccine HEP
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Malaise, Nausea, Retching, Vomiting
Symptom Text: Patient administered vaccine, then developed severe nausea and vomiting including "dry heaves" approximately 6 hours later, lasting for approximately 1 hour. Patient felt ill the following day, and had vomiting x1 that morning. Then patient fully recovered, none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none


Page 694
Onset Date Unknown
Days
State TX
Prev Doses 1
Site Right arm
ER VISIT, HOSPITALIZED, SERIOUS Erythema multiforme, Hypersensitivity
Symptom Text: See note (attached) 02/15/2007-record received and reviewed. Office visit of 02/08/07-Assessment. Allergic reaction on chest back and left arm. Patient thinks it is related to Gardasil. Received treatment in Mexico. Treated with Betamethasone. Diagnosed with erythema multiforme. Right arm at injection site is not irritated or edematous. Allergic reaction mostly in the contralateral side. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 695
Days 1
State TN
Last Edit Date 16-Feb-2007 Other Vaccine HPV4
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Oedema, Pruritus, Rash
Symptom Text: 16 year old female developed edema, rash and pruritus within 24 hours of receiving second Gardasil shot. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE oral contraceptives


Page 696
Onset Date Unknown
Days
State MD
Prev Doses 0
Site Right arm
Symptom Text: Nausea, dizziness Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Zoloft


Page 697
Days -1
State WA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, No adverse effect, Wrong drug administered
Symptom Text: Initial and follow up information has been received through the Merck regulatory pregnancy registry from a registered nurse at a health department and an unspecified family member concerning a 23 year old white female smoker who was 34 weeks pregnant with cervical incompetence, allergies to erythromycin and moxifloxacin hydrochloride (AVALOX) and had a history of premature labour from a prior pregnancy, a history of 3 pregnancies and 2 live births, a yeast infection, a threatened abortion, "ruptured membranes/delivery" and cervical dysplasia that had required a LEEP surgery, however, this procedure was not performed as the patient became pregnant. On 14-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpus". On 21-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus". On 02-MAY-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" and "gestational age, threatened abortion". On 26-JUN-2006, the patient underwent a maternal serum alphafetoprotein (MSAFP) which revealed "in range normal". It was reported that on an unspecified date, the patient had been hospitalized due to "lower back contractions". The patient had been diagnosed with a kidney infection and was advised to see her primary care physician for a flu shot. On 17OCT-2006, (conflicting information also reported as 20-OCT-2006), the patient went to her physician and received one dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) administered intramuscularly instead of the flu shot. Concomitant therapy included prenatal vitamins and unspecified therapies (reported as "tributylene", "suflexan" and "cyclomenzaprene"). On 16-OCT-2006 (conflicting information also reported as 20-OCT-2006), the patient was not having any adverse reaction. It was reported tha Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Test, Date, Value, Unit, Normal Range, Comment diagnostic nonstress test, 06/26/06, "maternal serum alphafetoprotein-in range normal" fetal nonstress test, 11/15/06 fetal nonstress test, 11/15/06 fetal nonstress test, 11/16/06 fetal no Hospitalisation: premature labour, yeast infection, artificial rupture of membrane, abortion threatened. Pregnancy NOS (LMP=3/1/2006), kidney infection, smoker, premature labour, cervical dysplasia, cervical incompetence, allergic reaction to antibiotic, hypersensitivity


Page 698
Days 0
State FL
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning an approximately 17 year old female with plantar warts since August 2005 who in August 2006, was vaccinated with fist dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. In September 2006, the patient received second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 1 month after the first dose. The patient sought medical attention. The physician noted as of 16-NOV-2006, the patient's plantar warts resolved. The patient noticed that the plantar warts resolved (on an unspecified date in 2006) after the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) was received. A different physician administered the HPV rL1 6 11 16 18 VLP vaccine (yeast). No other information was available at the time of reporting. Additional information was received from the physician who reported that is not an adverse event. The warts had been present for 2 years and were refractory to liquid nitrogen, imiquimod (ALDARA CREAM), and laser treatment. Additional information is not expected. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE plantar warts


Page 699
Days 0
Received Date 15-Feb-2007 Lot NULL NULL 427U7AA NULL NULL
State NC
Mfr Report Id WAES 0612USA02803 Route Subcutaneously Unknown Intramuscular Unknown Subcutaneously
Type VARCEL HIBV FLU HPV4 MMR
Manufacturer MERCK & CO. INC. MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC. MERCK & CO. INC.
Prev Doses 0 0 0
Site Unknown Unknown Unknown Unknown Unknown
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration, Pyrexia, Wrong drug administered
Symptom Text: Initial and follow up information has been received from a physician and an office manager concerning a 12 month old white female patient with no past medical history who on 15-DEC-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant vaccinations on the same day included a first dose of measles-mumps-rubella vaccine (MSD) SC into the left leg, Hib conj vaccine (OMPC) (manufacturer unknown) and a first dose of varicella virus vaccine live (MSD) SC into the left leg. Other concomitant vaccinations included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (lot# 427U7AA) IM into the right leg. It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) by accident. She was supposed to receive a dose of pneumococcal 4 6B 9V 14 18C 23F conj vaccine (CRM197) (PREVNAR). The reporter stated that the products were clearly labeled; there was not a confusion of products. It was "lack of education" of the medical assistant working on the office. The parents reported the patient had slight fever on 16-DEC-2006 (also reported as the 17-DEC-2006). Subsequently, the patient was seen in the office on 18-DEC-2006 and had recovered from slight fever. There were no there reported problems or "any other adverse events." Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Test, Date, Value, Unit, Normal Range, Comment-body temp, 12/17/06, slight fever NONE


Page 700
Days 0
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a nurse concerning her daughter, a 13 year old female who on 27-DEC-2006 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 27-DEC-2006 the patient developed dizziness and nausea. The patient's dizziness and nausea persisted. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 701
Vaers Id: 272276-1 Age Gender F 12.0 VAX Detail: Type TDAP MNQ FLU HPV4 Seriousness: MedDRA PT
Days 0
Received Date 15-Feb-2007 Lot NULL NULL NULL 0954F
State NH
Mfr Report Id WAES0701USA00266 Route Unknown Unknown Unknown Unknown
Manufacturer GLAXOSMITHKLINE BIOLOGICALS AVENTIS PASTEUR UNKNOWN MANUFACTURER MERCK & CO. INC.
Prev Doses
0 0
ER VISIT, NOT SERIOUS Fall, Feeling abnormal, Headache, Headache, Injury, Loss of consciousness, Pallor, Syncope
Symptom Text: Information has been received from a physician concerning a 12 year old female with no illness at the time of vaccination who on 08-DEC-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot 653938/0954F). On 08-DEC-2006, the patient was concomitantly vaccinated with a first dose of Menatra, a dose of influenza virus vaccine (unspecified) and a dose of Boostrix. On 08-Dec-2006, the patient fainted shortly after vaccination. She fell from a standing position and hit the back of head on the floor. She was unconscious for approximately 30 seconds,a and then was dazed and pale. The patient was "ok" after a few minutes. The patient complained of a headache, frontal to occipital. The patient was "ok" at home later that evening. The patient recovered with no sequalae on 08-DEC-2006. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 702
Days 50
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Human papilloma virus test positive
Symptom Text: Information has been received from a female patient who in November 2006, was vaccinated with the second dose of Gardasil (yeast). It was reported that the patient received the first vaccination in September 2006. On 21-Dec-2006, the patient underwent an "HPV DNA" test. The results indicated that the patient tested positive for HPV type 16. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory 12/21/06 - "HPV DNA" test positive for type 16 UNK


Page 703
Days 0
State NH
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Cough, Pyrexia, Sinus congestion
Symptom Text: Information has been received from a physician concerning a 24 year old female patient with NKDA who on 01-DEC-2006 was vaccinated into the left deltoid with a first dose of Gardasil (yeast) (lot#653978/0955F). At the time of vaccination the patient had "mild URI symptoms and a cold" with no fevers. In the week following vaccination, the patient developed a temperature of 101.5 and her URI progressed to sinus congestion and cough. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: body temperature 12/01?/06 101.5 NONE Cold; upper respiratory tract infection


Page 704
Onset Date Unknown
Days
State WA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypertension
Symptom Text: Information has been received from a physician concerning a 14 year old female who in approximately December 2006, " a few weeks ago," was vaccinated with a dose of Gardasil (yeast) (lot#654885/1424F). Subsequently, "after her first shot" the patient developed hypertension. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 705
Days 0
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 03-Jan-2007 was vaccinated with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 03-Jan-2007, after receiving the vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 706
Days 8
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner and healthcare worker concerning a 13 year old female who on 24-OCT-2006 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil (yeast) (lot# not reported). There was no concomitant medication. She was administered a second 0.5 ml dose of Gardasil (yeast), intramuscularly on 26-DEC-2006. It was reported that the patient, who has had her regular menses since the age of 10, had not had her regular menses in November 2006 or December 2006. The patient reported no other problems and was not reported to be pregnant. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 707
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Pain, Pain
Symptom Text: Information has been received from a registered pharmacist, also the patient, via a company representative, concerning herself. The pharmacist reported that during her second dose of Gardasil (yeast), she experienced a tremendous amount of stinging. She also noted that the second day after vaccination she was still very sore. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 708
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning four patients who were vaccinated with Gardasil (yeast). Subsequently the four patients experienced a fainting episode. At the time of the report, it was not reported if the four patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 709
Days 0
State OH
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of Gardasil (yeast). On 07-Dec-2006 the patient experienced significant arm pain, including through the passive motion. The physician reported that the patient was sent to see an orthopedic physician on 03-JAN-2007 because the patient was a dancer and could not dance with extreme pain. At the time of this report, the outcome was unknown. It was also reported that the patient was vaccinated with a first dose of Gardasil (yeast) on 12-OCT-2006 and there was no adverse experience with this initial dose. No product quality complaint involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 710
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of Gardasil (yeast) (lot number not reported). The nurse reported that the patient, after receiving the Gardasil (yeast), did not receive her next expected period. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 711
Days 0
State AZ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Incorrect route of drug administration, Injection site bruising, Injection site reaction, Injection site swelling
Symptom Text: Information has been received from al licensed practical nurse concerning a 17 year old female with no pertinent medical history, who on 02-JAN-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. The nurse reported that the patient received the vaccination via the subcutaneous route and on 02-JAN-2007, developed in injection site reaction. The reaction was described as being that of a swollen and bruised injections site on the patients shoulder. Unspecified medical attention was sought. The patient subsequently recovered on 03-JAN-2007. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 712
Onset Date Unknown
Days
State MI
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. subsequently, following vaccination, the patient loss consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 713
Onset Date Unknown
Days
State CA
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently, following the second vaccination, the patient experienced irregular periods. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 714
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who on an unspecified date was vaccinated with the first dose of Gardasil, injection, 0.5ml. Concomitant medications was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of Gardasil. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from rash on her chest and arm. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 715
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female with pertinent medical history reported as none and allergic reaction to some antibiotics who on 06-SEP-2006 was vaccinated with the first dose of Gardasil. Concomitant medication was reported as none. On approximately 06SEP-2006, the patient developed injection site pain that lasted 3 days following vaccination with Gardasil. On an unspecified date, the patient sought unspecified medical attention. On approximately 08-SEP-2006, the patient recovered from injection site pain. The patient had not received her second dose of Gardasil. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic reaction to antibiotics.


Page 716
Days 2
State WV
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pregnancy test negative, Uterine haemorrhage
Symptom Text: Information has been received from a registered nurse and physician assistant certified concerning a 16 year old female with on known drug allergies, no illness at time of being vaccinated, and no medical history who on 30-DEC-2006 was vaccinated with first dose of Gardasil (lot #654741/1208F) intramuscularly left deltoid at 1400 hours. There was no concomitant medication. On 01-JAN-2007, at 1400 hours the patient experienced abnormal uterine bleeding (Spotting) uncomplicated and sought medical attention. The patient already had her period (normal menses 27-DEC-2006) and had been "spotting all during this past week". They thought pregnancy was possible so they administered a urine pregnancy test (negative) and she was not pregnant. She had no abdominal pain and no previous history of abnormal uterine bleeding. The outcome of the uterine bleeding was not reported. Additional information has been requested. NONE Other Meds: Urine beta human 01/01/07 negative Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 717
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Diarrhoea, Vomiting
Symptom Text: Information has been received from a registered nurse concerning her niece a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who in 2006 was vaccinated with the first and second doses of Gardasil, IM (1st and 2nd dose over a two month period). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced vomiting and diarrhea after the first and second doses of Gardasil series. The patient sought unspecified medical attention. The nurse reported that the patient does not plan to have the third dose as recommended. Subsequently on an unspecified date, the patient recovered from vomiting and diarrhea. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 718
Days 9
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Headache, Injection site rash, Tenderness
Symptom Text: Information has been received from a physician and the mother of a 12 year old female with pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with the first dose of Gardasil (lot #655165/1425F). concomitant therapy included tetanus toxoid. On 28-DEC-2006, the patient experienced a rash at the injection site right after receiving the vaccination. The patient also experienced mild headaches almost immediately. A few days later the patient's headaches became more intense. The patient still experienced intermittent headaches but the severity has not decreased. On 31-DEC2006, the patient presented to the physician office and complained that she had a headache for four days. The patient was told by the physician to increase the dosage of Motrin. On 01-JAN-2007, the patient presented to the physician office again and stated that she was not better and still had a headache. The physician stated when the patient pressed over her sinus area it seemed tender. The patient was treated with oral antibiotics. The patients headache persisted. Additional information has been requested. Tetanus toxoid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 719
Days 1
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pain in extremity, Paraesthesia
Symptom Text: Information has been received from a pharmacy intern concerning an 18 year old female with no pertinent medical history and no known adverse drug reactions and no known allergies reported. On 04-JAN-2007, the patient was vaccinated intramuscularly in the left arm with the first 0.5ml dose of Gardasil (lot #653736/0689F). There were no concomitant medications reported. On 05-JAN-2007, in the morning, the patient developed tingling in the fingers and her left hand with pain in the fingertips when touching anything. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 720
Days 7
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Rash, Rash
Symptom Text: Information has been received from a physician concerning a female (age not reported) with a sulfonamide allergy and no other pertinent medical history reported. On 22-DEC-2006, the patient was vaccinated with 0.5ml of Gardasil ( Lot #655165/1425F). There were no concomitant medications reported. On 29DEC-2006, one week after the injection, the patient developed a rash on her arms, legs and abdomen. The patient sought unspecified medical attention. It was reported that the rash had since cleared up but the date was unknown. At the time of this report, the patient had recovered from the event. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Sulfonamide allergy


Page 721
Onset Date Unknown
Days
State NY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 25 year old female with no drug allergies who on 27-Dec-2006 was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included ZITHROMAX. Subsequently, on an unspecified date, the patient experienced nausea and dizziness. The patient did not seek medical attention. No diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. ZITHROMAX Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 722
Onset Date Unknown
Days
State KY
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a first and second dose of Gardasil (yeast). Subsequently the patient fainted 15 minutes after each vaccination. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 723
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 23 year old female office employee in her office with drug reactions/allergies and pertinent medical history reported as unspecified who on an unspecified date was vaccinated with first dose of Gardasil (yeast) (lot# not reported) intramuscularly. Concomitant therapy was unspecified. On an unspecified date, the patient was vaccinated in the gluteal area and she experienced injection site pain. The patient sought medical attention. At the time of reporting, the outcome of the event was unspecified. No other information was provided. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 724
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Influenza like illness, Stomach discomfort
Symptom Text: Information has been received from a nurse practitioner concerning her 18 year old daughter with drug reactions/allergies and medical history reported as unspecified who in approximately 2007 was vaccinated with second dose of Gardasil (yeast) (lot # not reported) 0.5 ml intramuscularly. Concomitant medication was unspecified. In approximately 2007, after the second dose of Gardasil (yeast), the patient experienced dizziness, and stomach upset. They were flu-like symptoms. The patient sought medical attention. At the time of reporting, the patient had recovered. No additional information was available at the time of reporting. Additional has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 725
Days 0
State KY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a medical assistant concerning a 16 year old female with drug reactions/allergies to CECLOR and penicillin who on 13OCT-2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (yeast), (lot#653978/0955F). Concomitant therapy included OVRAL. It was reported the patient fainted with the first vaccination. On 13-DEC-2006, the patient was vaccinated intramuscularly with the second 0.5 ml dose of Gardasil (yeast) (lot#65389/0961F). The patient lay down for 25 minutes after the vaccination to prevent fainting. It was reported that the patient fainted again while she walked out to the waiting room. The patient recovered on the same day. Additional information has been requested. OVRAL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: allergic reaction to antibiotics; Penicillin allergy NONE


Page 726
Days 0
State KY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 20 year old female who on 05-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil (yeast). Concomitant therapy included hormonal contraceptives (unspecified). The physician reported that the patient was extremely nervous about getting the shot. Later that evening, within 12 hours, the patient broke out in hives. The physician told the patient to go to the emergency room (ER). The patient went to the ER and was given BENADRYL for the hives. The physician reported that the patient was fine, but does not plan to give the patient anymore shots. There was no lot number provided. At the time of this report, it was noted that the patient was "fine after she had received BENADRYL. Additional information has been requested. hormonal contraceptives Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Nervousness


Page 727
Days 2
State MI
Prev Doses 0
Site Unknown
Symptom Text: Initial information has been received from a physician via a company representative and follow-up information has been received from the physician concerning a 14 year old female student who, on 20-NOV-2006, was vaccinated with a 0.5 ml dose of Gardasil (yeast) (lot# not reported). There was no concomitant medication. Subsequently, on approximately 22-NOV-2006 or 23-NOV-2006, the patient developed a bad acne breakout. The physician reported that the patient developed "giant pimples" the likes of which she'd not experienced previously. The patient was reported to have been using over the counter acne wash which had been working well up to this point. The patient was put on oral antibiotics and given a topical wash for the breakout, which occurred on her face, chest and back. The patient's acne breakout was continuing at the time of the report. Additional information has been requested. NONE Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 728
Days 16
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dyspnoea
Symptom Text: Information has been received from a physician concerning a 15 year old female patient with allergic rhinitis who on 20-OCT-2006 was vaccinated intramuscularly in the morning with a first dose of Gardasil (yeast) (lot#653735/0688F). Illness at the time of vaccination included pharynigitis. Concomitant therapy included amoxicillin. In the evening of 05-NOV-2006, three weeks after vaccination, the patient developed shortness of breath. The patient had no history of asthma. Subsequently, on an unspecified date, the patient recovered. Additional information is not expected. amoxicillin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pharynigitis, Rhinitis allergic UNK


Page 729
Days 0
State CA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Bronchospasm, Cough
Symptom Text: Information has been received from a registered nurse concerning a 13 year old female with asthma and allergic eczema who on 10-NOV-2006 at 12:00PM, was vaccinated in the right arm intramuscularly with a first 0.5 ml dose of Gardasil (yeast) (lot#653978/0955F). Concomitant suspect vaccination included a dose of tetanus toxoidon 10-NOV-2004. Other concomitant therapy included albuterol and ZYRTEC. There was no illness at the time of vaccination. On 10Nov-2006 the patient experienced bronchospasm 20 minutes after receiving Gardasil (yeast). It was also reported that the patient developed a cough but she did not vomit. The patient used her albuterol inhaler and then rested and was recovered on the same day, 10-NOV-2006. No vomiting and no other anaphylaxis type reaction was noted. Additional information is not expected. albuterol, ZYRTEC, tetanus toxoid Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Asthma, Allergic eczema


Page 730
Days 1
State MA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female with asthma and no known allergies or adverse drug reactions reported. On 08-JAN-2007, the patient was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (yeast) (lot#655165/1425F). Concomitant therapy included hormonal contraceptives (unspecified) and albuterol. On 09-JAN-2007, the patient developed a rash on her back and chest. The patient sought unspecified medical attention. The patient was being treated with BENADRYL. At the time of this report, the patient had not recovered from the event. albuterol, hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma NONE


Page 731
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Malaise, Nausea, Syncope
Symptom Text: Information has been received from a physician concerning a 19 year old female with a penicillin allergy and no other pertinent medical history reported. On 22DEC-2006, the patient was vaccinated intramuscularly with one dose of Gardasil (Lot #654885/1424F). Concomitant therapy included Ortho Tri Cyclen. On 22DEC-2006, the patient felt nauseous shortly after administration. The patient then fainted for approximately 10 seconds while she was at the office. The patient remained in the office until she felt normal again. The patient then went home where later she felt sick again. The patient went to the emergency room and was then released. It was reported that there were no laboratory diagnostics performed at the physician's office and it was unknown it any were performed in the emergency room. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested. Ortho Tri Cyclen Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 732
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Chills, Pyrexia
Symptom Text: Information has been received from a physician concerning a 20 year old female patient with no allergies or medical history who on 09-NOV-2006, was vaccinated with the first 0.5 L, dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot unspecified). Concomitant therapy included penicillin. On 09-NOV-2006, at 1:30 P.M., the patient developed chills and fever of 102.7 degrees on 10-NOV-2006 at 7:00 P.M. The patient did not seek medical attention. The patient treated herself with acetaminophen (TYLENOL). The patient's symptoms lasted until noon on 11-NOV-2006. Additional information has been requested. penicillin (unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: test, date, value unit, normal range, comment body temp, 11/10/06, 102.7 degr NONE


Page 733
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reaction/allergies not reported who on 29-DEC-2006 was vaccinated with the first dose of Gardasil (Lot #654885/1424F), injection, 0.5ml. Concomitant medication was not reported. ON 29-DEC2006, the patient developed hives within hours of receiving the first dose of Gardasil. The physician reported that the hives became more generalized within 24 hours. On 29-DEC-2006, therapy with human papillomavirus vaccine was discontinued. Subsequently on an unspecified date, the patient recovered from hives. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 734
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy, Nausea
Symptom Text: Information has been received from a consumer through the pregnancy registry concerning a 15 year old daughter with pet allergies who on 08-JAN-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included prenatal medication (therapy unspecified) and erythromycin. On 08-JAN-2007, the patient was vaccinated with Gardasil and the patient was 14 weeks pregnant. The clinic administered the vaccine without confirming if her daughter was pregnant. The consumer stated that her daughter has experienced nausea since she received Gardasil. The physician did not administer the vaccine to the patient as she received the vaccination at a clinic. On 08-JAN-2007 therapy with Gardasil was discontinued. The outcome of the events was not reported. Additional information has been requested. Therapy unspecified, erythromycin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP Unknown) allergy to animal


Page 735
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Loss of consciousness, Paraesthesia
Symptom Text: Information has been received from a physician's assistant concerning a female who on 08-JAN-2007 was vaccinated intramuscularly with a dose of Gardasil. Subsequently the patient passed out and experienced tingling sensation from her shoulder to her fingertips. It was reported that the patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 736
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Lymphadenopathy, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced swollen lymph nodes on the same side as the injection two days after receiving the injection. The patient recovered from the swollen lymph nodes after the first injection with Gardasil. Two days after the second dose of Gardasil, the patient again experienced swollen lymph nodes on the same side as the injection. Clinical outcome related to the second occurrence of swollen lymph nodes in unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 737
Days 0
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pain, Oedema peripheral, Pain in extremity
Symptom Text: Information has been received from a health professional concerning a female pharmacist who on 02-JAN-2007 was vaccinated with a second dose of Gardasil. On 02-JAN-2007, the patient experienced a strong stinging sensation during vaccination. After vaccination, her arm swelled and was very sore. On 03-JAN-2007, the patient recovered. It was reported that the patient did not experience any of these symptoms with the first vaccination with Gardasil. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 738
Days 0
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse and a physician via a company representative concerning an 18 year old female who on 27-DEC-2006 was vaccinated intramuscularly with one dose of Gardasil (lot 653978/0955F). On 27-DEC-2006 the patient passed out after getting Gardasil. The patient sought unspecified medical attention. It was not reported if the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 739
Days 6
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning her daughter, a 20 year old female with possible human papilloma virus prior to May 2006 who had an abnormal Papanicolaou (PAP) smear and colposcopy, June 2006 who on 21-NOV2006 was vaccinated with a 0.5ml dose of Gardasil. Concomitant therapy included Yasmin. On 27-NOV-2006, the patient developed genital warts. The patient required laser surgery on 08-JAN-2007. Laboratory evaluation included hemoglobin. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested. Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Hemoglobin Papanicolaou smear abnormal Surgery


Page 740
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dysmenorrhoea
Symptom Text: Information has been received from a physician concerning a 16 year old female patient with on pertinent medical history or drug reactions/allergies, who on 10-NOV-2006 was vaccinated intramuscularly with the first dose of Gardasil (lot #653937/0637F). There was no concomitant medication. Subsequently, on an unspecified, the patient experienced severe cramping during her menstrual cycle. Unspecified medical attention was sought. The physician stated that no further doses of Gardasil will be given until further information was received. At the time of this report, the patient was recovering. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 741
Days 2
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Contusion
Symptom Text: Information has been received from a physician and a certified medical assistant concerning a 14 year old female with no pertinent medical history who on 10NOV-2006 was vaccinated IM with a first dose of Gardasil (lot #653937/0637F). There was no concomitant medication. On 12-NOV-2006 the patient developed "bad bruise". Unspecified medical attention was sought. On approximately 29-NOV-2006, the patient recovered. There were no laboratory or diagnostic tests performed. The physician reported that no further doses of Gardasil will be given until further information is received. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 742
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 20 year old female who on 22-DEC-2006 was vaccinated with Gardasil (yeast) (lot number 653978/0955F). On 22-DEC-2006 the patient passed out after vaccination. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 743
Days 2
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Chills, Pain, Pyrexia
Symptom Text: Information has been received from a physician concerning a 19 year old female who on 08-Jan-2007 was vaccinated with Gardasil (yeast) (lot number 655165/1425F) 0.5 ml intramuscularly. On 10-JAN-2007 the patient experienced 102 degrees F fever, chills and body aches for "the past 10 hours". The patient's 102 degrees F fever and chills and body aches persisted. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 744
Days 7
State NJ
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Rash, Upper respiratory tract infection
Symptom Text: Information has been received from an office manager concerning a female patient who on 01-DEC-2006 was vaccinated with a dose of Gardasil (yeast). One week later the patient developed a rash and an upper respiratory tract infection. She was treated with BENADRYL and ORAPRED. The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 745
Days 5
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Dizziness
Symptom Text: Information has been received from an R.N. concerning a 19 year old female patient who on 09-JAN-2007 was vaccinated IM with a dose of GARDASIL (lot #653978/0955F) and felt dizzy and lightheaded. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 746
Days 0
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who on 08-JAN-2007 was vaccinated IM with a dose of Gardasil (yeast). It was noted that the patient fainted during the administration of the vaccine, the patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 747
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil (yeast). Subsequently the patient fainted. Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 748
Days 0
State OH
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Feeling abnormal
Symptom Text: Information has been received from a registered nurse concerning a 26 year old female with no medical history or allergies, who on 04-JAN-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 04-JAN-2007 the patient felt dizzy and had a sensation of hands being pressed down on her head. No other symptoms were noted. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The symptoms lasted about 15 to 20 minutes and then resolved. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 749
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of Gardasil (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 750
Onset Date Unknown
Days
State IA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Inflammation, Pain in extremity, Physiotherapy, Radiculitis brachial
Symptom Text: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with the first dose of Gardasil (yeast). Subsequent following vaccination, the patient experiences extreme pain in the arm and inflammation. The patient underwent physical therapy and was diagnosed as having brachial neuritis. It was not specified if the series of Gardasil (yeast) would be completed. At the time of this report, the patient was recovering from the brachial neuritis. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: magnetic resonance - narrative UNK


Page 751
Vaers Id: 272326-1 (S) Age Gender Vaccine Date F 04-Oct-2006 16.0 VAX Detail: Type HPV4 HEPA
Days 3
Received Date 15-Feb-2007 Lot 0689F NULL
State NY
Prev Doses 0
ER VISIT, PERMANENT DISABILITY, SERIOUS Vaccine positive rechallenge, Vomiting
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female with an aspirin allergy who on 04-OCT-2006 at 16:00 and 11-DEC-2006 at 14:30 was vaccinated IM into the right deltoid with a first and second dose of Gardasil (first dose lot #653736/0689F, second dose lot #654510/0962F). Concomitant therapy given on 04-OCT-2006 and 11-DEC-2006 included a dose of Havrix. Three days after the first dose, the patient vomited for 2 days and was out of school. Three days after the second dose the patient threw up a lot more for 2 days and was out of school. The nurse was concerned about this patient and considered her condition to be disabling since she missed school for two days after each dose. Unspecified medical attention was sought. No diagnostic laboratory studied were performed. No product quality complaint was involved. Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Drug hypersensitivity NONE


Page 752
Onset Date Unknown
Days
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Musculoskeletal pain
Symptom Text: Information has been received from a licensed practical nurse concerning a female with no pertinent medical history and no known allergies who on 21-DEC2006 was vaccinated into the right arm with a 0.5 ml first dose of Gardasil (yeast) (lot#654389/0961F). Concomitant therapy included unspecified over the counter vitamin supplements. Subsequently the patient experienced severe deep pain in her right shoulder. Unspecified medical attention was sought and there was no treatment given. At the time of the report, the patient had not recovered. Additional information has been requested. vitamins (unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 753
Days 0
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 12 year old female with diabetes and eczema who on approximately 07-JAN-2007 was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) concomitantly with a dose of an unspecified vaccine. On approximately 07-JAN-2007, later in the night, the patient developed hives all over her body, mostly on her legs. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK diabetes, eczema


Page 754
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Pain, Syncope
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 755
Days 29
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS HIV test false positive
Symptom Text: Information has been received from a physician concerning a 17 year old female with no medical history or allergies, who on 14-AUG-2006 on 02-NOV-2006 was vaccinated IM with a first and second 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. In December 2006, the patient had a false positive HIV result. It was noted that the physician stated that the patient had no risk factors for HIV. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Serum HIV-1 p24, 12/06, false positive NONE


Page 756
Onset Date Unknown
Days
State WA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the felt faint post vaccination. The patient sought unspecified medical attention. At the time of this report, it was unknown if the patient had recovered from the event. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 757
Onset Date Unknown
Days
State WA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the patient felt faint post vaccination. The patient sought unspecified medical attention. At the time of this report, it was unknown if the patient had recovered from the event. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 758
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 13 year old female who on 12-DEC-2006 was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain down her arm one month after receiving her second dose. The patient's pain down her arm persisted. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 759
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure, Syncope
Symptom Text: Information has been received from a physician concerning a 13 year old female who on 12-JAN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml intramuscularly. The patient fainted when she got outside in the parking lot of the physician's office (also reported as within 10 minutes). The patient was brought back into the physician's office and "let rest for a while". The physician checked the patient's blood pressure (no details provided). The physician noted that the patient is "fine now". Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 760
Days 1
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fluid retention, Weight increased
Symptom Text: Information has been received from a medical assistant concerning a 38 year old female with edema who on 07-DEC-2006 was vaccinated IM, into the deltoid, with a 0.5 ml first dose of Gardasil (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On 08-Dec-2006 the patient "gained 13 pounds of water weight". Medical attention was sought and the patient was treated with unspecified diuretics. On approximately 29-Dec-2006, the patient recovered from "gained 13 pounds of water weight". Additional information has been requested. Hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Edema UNK


Page 761
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse concerning a female who on 19-SEP-2006 was vaccinated IM with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain at the injection site. Unspecified medical attention was sought. It was reported that the patient did not return to complete the schedule. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 762
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Discomfort, Dizziness, Incorrect route of drug administration
Symptom Text: Information has been received from a health professional concerning a 21 year old female patient with a history of anemia who on 16-NOV-2006 was vaccinated SC with a first 0.5 ml dose of Gardasil (yeast) (lot#653938/0954F). The patient reported feeling lightheaded and uncomfortable after the first dose was given. No further information was provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Anemia


Page 763
Days 4
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Loss of consciousness, Paraesthesia
Symptom Text: Information has been received from a nurse concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on 28-DEC-2006 was vaccinated with Gardasil (yeast) (lot# not reported) injection. Concomitant therapy unspecified. On 01-Jan-2007, the patient passed out. Medical attention was sought. The patient later reported that she was experiencing light headedness and tingling in her hands and feet on 02-JAN-2007. The patient was referred to a cardiologist. The patient had a carotid ultrasound and echocardiogram performed on 05-JAN-2007 and 11-JAN-2007, respectively (results not reported). At the time of reporting, the tingling in her hands and feet persisted. No further information was available at the time of reporting. Additional information has been requested. UNK Other Meds: carotid artery 01/05/07 - result not reported, echocardiography 01/11/07 - result not reported Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 764
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dysmenorrhoea
Symptom Text: Information has been received from a physician concerning a female who was vaccinated, intramuscularly with the first, 0.5 ml dose of Gardasil. The patient concomitantly received Menactra and Dtap. The patient complained that her subsequent menstrual period was "much more painful than usual" with severe menstrual cramping. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested. Therapy unspecified, Menactra, Dtap Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 765
Vaers Id: 272340-1 Age Gender F 11.0 VAX Detail: Type TDAP HPV4 HEPA MNQ Seriousness: MedDRA PT
Days 0
Received Date 15-Feb-2007 Lot C2455AA NULL 652809/1008F U2002AC
State CA
Mfr Report Id WAES 0701USA0111 Route Intramuscular Unknown Intramuscular Intramuscular
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Injection site anaesthesia, Injection site pain, Paraesthesia, Similar reaction on previous exposure to drug
Symptom Text: Information has been received from registered nurse concerning a 11 year old female who on 11-OCT-2006 at 15:30, was vaccinated with the first dose of Gardasil (yeast) (lot number 654540/0800F) intramuscularly in the left deltoid. Concomitant vaccinations included hepatitis A vaccine (inactive) (MSD) (lot number 652809/1008F) intramuscularly in the right deltoid, meningococcal ACYW conj vaccine (MENACTRA) (lot number U2002AC) intramusculary in the right deltoid and (ADACEL) (lot number C2455AA) intramuscularly in the left deltoid. On 11-OCT-206 the patient stated that her arm tingled and felt numb at the injection site (arm not specified). Tingling and numbness lasted one hour. After that the patient stated the arm was just sore at the injection site. On 27-DEC2006 was vaccinated with the second dose of Gardasil vaccine (yeast). On 27-DEC-2006 the patient again experienced arm tingled at injection site, but it "just lasted a few minutes". Additional information is not expected. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 766
Days 0
State WA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Oedema peripheral, Pain in extremity
Symptom Text: Information has been received from a registered nurse concerning a female patient who on approximately 16-Nov-2006, about two months ago, was vaccinated with a 0.5 ml dose of Gardasil. On approximately 16-Nov-2006, the patient developed swelling of the arm (unspecified) after the injection and experienced pain in her whole arm. The patient sought unspecified medical attention. The patients arm pain persisted. although, the outcome of the patients arm swelling was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 767
Days 0
State WA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Contusion, Injection site swelling, Tenderness
Symptom Text: Information has been received from an R.N. concerning a 22 year old female patient with an allergy to codeine who on 11-NOV-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast); and according to the nurse, developed severe swelling on the injection site arm after the first dose. The patient received the first vaccination at another office and no information was available on where the first vaccination was administered or the physician involved in the first vaccination. On 16-JAN-2007 the patient was seen in the office. She was breast feeding, and was reported to have been breast feeding when the first vaccination was administered. The patient reported that she had developed an egg shaped swelling at the injection site on the left upper arm that lasted for more than one week after the first vaccination. No timeline on the development of the swelling in relation to the vaccination was available. The arm was still bruised and tender 2 months after the first vaccination. The second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) has not been administered. At the time of the report, the patient was recovering. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK hypersensitivity


Page 768
Days 0
State FL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Injection site swelling, Oedema peripheral
Symptom Text: Information has been received from a RN concerning a 13 year old female patient who on 15-Jan-2007 was vaccinated IM with a dose of Gardasil, lot #6536978/0955F. Several hours later, the patient experienced pain and swelling at injection site and extending into her hand. There were no other symptoms noted. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 769
Onset Date Unknown
Days
State MI
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 770
Onset Date Unknown
Days
State MI
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 771
Onset Date Unknown
Days
State MI
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 772
Days 0
State OH
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female who on 27-DEC-2006 was vaccinated in the arm (unspecified) with the first dose of Gardasil (lot #654885/1424F). There was no concomitant medication. On 24-DEC-2006, the patient developed a rash up and down both arms. The patient's rash was treated with Benadryl. Subsequently, after three days, the patient recovered from the rash. It was reported that the event did not require an emergency room/doctor visit. Additional information is not expected. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 773
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot number not reported). The nurse reported that the patient, after receiving the Gardasil, did not received her next expected period. The patient sought unspecified medical attention. At the time of this report. the outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 774
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Menstruation delayed
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with dose (lot number not reported). The nurse reported that the patient, after receiving the Gardasil, did not received her next expected period. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 775
Days 0
State VA
Prev Doses 0
ER VISIT, NOT SERIOUS Injection site irritation, Loss of consciousness, Vomiting
Symptom Text: Information has been received from a 24 year old female with an unremarkable medical history and no known allergies or adverse drug reactions reported. In November 2006, the patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of Gardasil. concomitant therapy included influenza virus vaccine (unspecified) and hormonal contraceptives (unspecified). In November 2006, right after she received her first injection of Gardasil, the patient vomited and the passed out. The patient developed burning at injection site. The patient sought unspecified medical attention. It was reported that the patient was alright after about 20 minutes after the injection. The patient plans to receive her second shot on 17-JAN-2007. In November 2006, the same day that the first dose of the vaccine was administered, the patient had recovered from the events. Additional information has been requested. Hormonal contraceptives, influenza virus vaccine Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns:


Page 776
Days 2
State NY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 20 year old female with high blood pressure and an allergy to sulfa. On 08-Jan-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of Gardasil (lot #655619/1427F). Concomitant therapy included Micronor. On 10-JAN-2007, the patient developed intermittent hives. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested. Micronor Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Blood pressure high, sulfonamide allergy.


Page 777
Days 0
State WA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a 26 year old female with a drug hypersensitivity to tetracycline, prochlorperazine maleate (COMPAZINE) and doxycycline and no other pertinent medical history reported. On 15-JAN-2007, the patient was vaccinated intramuscularly with HPV rL1 6 12 16 18 VLP vaccine (yeast). Concomitant therapy included a "steroid shot" and unspecified hormonal contraceptives. On 15-JAN-2007, the patient developed a terrible rash. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested. corticosteroids, hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE drug hypersensitivity


Page 778
Days 0
State MI
Site Unknown
ER VISIT, NOT SERIOUS Dysgeusia, Vaccine positive rechallenge
Symptom Text: Information has been received from a licensed partner nurse concerning her 20 year old white daughter student with pertinent medical history and drug reactions/allergies reported as unspecified who on 01-NOV-2006 was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0702F) IM left arm at 1500 hours. On approximately 17-JAN-2007, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). Following each dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient experienced a metallic taste. The metallic taste was more pronounced after the first dose. The patient sought medical attention. Subsequently, the patient recovered. No other information was available at the time of reporting. Additional information was received from the licensed practical nurse. The patient complained of strong "metal" taste at the back of her tongue immediately after the first injection. This odd taste sensation lasted somewhere between 30 and 60 seconds and then slowly disappeared after 2 to 3 minutes. No additional information is expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 779
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Injection site swelling, Syncope
Symptom Text: Information has been received from a physician concerning several females who on unspecified dates were vaccinated with Gardasil 0.5 ml by injection. Subsequently, several patients fainted after receiving Gardasil and several patients experienced pain and swelling at the injection site. Medical attention was sought. The outcome of the events was unspecified. No additional information is available. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 780
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician's assistant concerning a 15 year old female who on unspecified dates was vaccinated intramuscularly in the arm with the first and second dose of Gardasil. Within 24 hours of receiving the first and second dose of Gardasil the patient developed a localized rash on the forearm. It was reported that the patient went to a dermatologist for the rash. It was reported that the events disappeared after a day or so. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 781
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient developed a rash. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 782
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site irritation, Injection site pain, Injection site swelling
Symptom Text: Information has been received from a registered nurse concerning "several" patients who were vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patients subsequently complained of a little arm soreness after the vaccination. All patients recovered from arm soreness. On unknown dates, patients were vaccinated with second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patients experienced pain, swelling and irritation at injection site. The nurse noted that she used 3 or 4 different lots, and the patients were complaining that "it hurt quite a bit when the medicine was being injected into the arm". The nurse further commented that the patients did not complain about this with the first dose. The patients went home after the office visit. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 783
Days 1
State MA
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Diarrhoea, Vomiting
Symptom Text: Pt recived vaccine 5pm 2/8/07. Pt begain vomiting and diarrhea 4am 2/9/07. Pt had no fever. Pt given IV fluids. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None No


Page 784
Days 2
Received Date 15-Feb-2007 Lot 1140F 0651F 0637F
State CA
Type VARCEL HEPA HPV4
Prev Doses 1 1
Right arm
NO CONDITIONS, NOT SERIOUS Erythema, Induration
Symptom Text: Left upper, outer arm, 4 cm induration with erythema. Benadryl, Motrin RTC Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 785
Vaers Id: 272387-1 Age Gender U Unknown VAX Detail: Type TDAP HPV4 Seriousness: MedDRA PT
Days 0
Received Date 15-Feb-2007 Lot AC52B009AA NULL
State --
Prev Doses 0 2
Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Dyspnoea, Heart rate increased, Tremor
Symptom Text: C/O dizziness "can't breath" observed tremor of hands states heart beating rapidly (AP=72/min) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Exercise induced asthma. URI and pharyngitis


Page 786
Days 1
Received Date 16-Feb-2007 Lot 1065F 0962F AC52B007AA U1892AA
State MI
Type VARCEL HPV4 TDAP MNQ
Manufacturer MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS AVENTIS PASTEUR
Prev Doses 1 0 0 0
NO CONDITIONS, NOT SERIOUS Dizziness, Headache, Hypotension, Somnolence, Vomiting
Symptom Text: Early in the am of 2/2/2007, patient woke with sudden onset of vomiting, dizziness, and severe headaches. Seen by primary care physician later in the day with noticeable hypotension. Remained in bed over the weekend, sleeping most of the time and taking Motrin for headache. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 787
Days 30
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, Pregnancy, Systemic lupus erythematosus
Symptom Text: Information has been received from a 26 year old female consumer with migraine headaches, who on approximately 31-OCT-2006 ("end of October or beginning of November 2006"), was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included propranolol HCL for migraine headaches. Subsequently, the patient "became pregnant at the end of November 2006," and reported " a normal pregnancy with no adverse side effects". The approximate LMP date was 30-NOV-2006, with an estimated due date of 06-SEP-2007. Additionally, on approximately 28-DEC-2006 ("approximately six weeks ago"), the patient was diagnosed with lupus (not further specified), and daily injections of LOVENOX were initiated as treatment. Unspecified blood tests were performed (results not reported). At the time of the report, the patient had not recovered. Upon internal review, the patient's diagnosis of lupus was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested. Propranolol Hydrochloride Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP= 11/30/2006), Migraine diagnostic laboratory 11?/??/06 -


Page 788
Days 1
State CA
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Brain scan normal, Condition aggravated, Dystonia, Pain, Tic, Torticollis
Symptom Text: Information has been received from a health professional concerning a 14 year old female with allergies to Prozac and Seroquel and a history of dystonic reaction involving the right arm, right leg and neck in 2006 caused by an allergic reaction to Seroquel who on 12-JAN-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and Prevacid. On 13-JAN-2007 the patient experienced a tic disorder involving her head and neck. The patient also had a rapid, involuntary, spasmodic dystonic reaction and torticollis like movement that appeared painful and continued during sleep. On 13-JAN-2007, the patient was examined in the emergency room and was given Benadryl and Ativan and was released. A CT scan of the brain was negative. On 15-JAN-2007, she was examined by her primary care physician and was given Benadryl IM. She was later examined on 15-JAN2007 by a neurologist and was given Cogentin IM and was started on oral benztropine mesylate (MSD). ON 17-JAN-2007, 19-JAN-2007, and 05-FEB-2007, the patient was also examined by a neurologist. On 19-JAN-2007 the symptoms began to resolve and on 05-FEB-2007 completely resolved. The patient will continue with Cogentin until 19-FEB-2007. Tic disorder, rapid, involuntary, spasmic dystonic reaction and torticollis like movement were considered to be other important medical events and disabling. Additional information has been requested. Hormonal contraceptives, Prevacid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: head computed axial 01/13/07 - negative Dystonic reaction Drug hypersensitivity


Page 789
Vaers Id: 272477-1 Age Gender F Unknown VAX Detail: Type MNQ HPV4 DTAP Seriousness: MedDRA PT
Onset Date Unknown
Days
Received Date 15-Feb-2007 Lot NULL NULL NULL
State OH
Mfr Report Id WAES 0701USA02867 Route Unknown Unknown Unknown
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. UNKNOWN MANUFACTURER
Prev Doses
NO CONDITIONS, NOT SERIOUS Injection site induration
Symptom Text: Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) concomitantly with a dose of MENACTRA and a dose of DTaP. Subsequently the patient developed knot at the injection site where she received DTaP. It was reported that the patient with a knot or "raised area" that was 1 and 1/2 inches long. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 790
Days 0
State CT
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Influenza like illness, Malaise, Myalgia
Symptom Text: Information has been received from a physician concerning a female who on 17-JAN-2007 was vaccinated with a 0.5 ml first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 17-JAN-2007 the patient experienced flu-like symptoms described as malaise and myalgia. Unspecified medical attention was sought. At the time of the report, the patient was recovering. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 791
Days 0
State NY
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Flushing, Nausea
Symptom Text: Information has been received from a health professional concerning a 21 year old white female with no medical history, who on 21-DEC-2006 was vaccinated in the left deltoid with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653735/0688F). There were no illnesses at the time of vaccination. On 21-DEC-2006, following vaccination, the patient felt faint and queasy and her face appeared flush. The patient's blood pressure was 102/60. The patient was given a cold drink of water and a cold compress and remained seated for 10 minutes and subsequently felt fine. The patient stated that "needles make her scared". No further information is expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure, 12/21/06, 102/60 NONE


Page 792
Days 0
State VA
ER VISIT, NOT SERIOUS Injection site discolouration, Injection site pain
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female with no past medical history and no drug allergies who on 08-NOV2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653978/0955F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included minocycline HCl (MINOCIN). On 08-NOV-2006 the patient experienced skin discoloration around injection site. The discoloration was slightly lighter than her skin color and was shaped like a "C" to the other side was 20 mm. The area was not raised or sore. She mentioned that she had some mild soreness at the injection site for one to two days after the vaccine was initially administered. The patient had no other symptoms. There were no relevant diagnostic tests performed. Unspecified medical attention was sought. Additional information has been requested. Minocin Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 793
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fatigue
Symptom Text: Information has been received from a physician concerning a female who on 14-DEC-2006 was vaccinated by injection with the first dose of HPV vaccine (yeast). On 14-DEC-2006 the patient experienced fatigue after HPV vaccine (yeast) was administered. The patient received the second dose of HPV vaccine (yeast) on 15-JAN-2007 and did not experience any further symptoms. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient had recovered. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 794
Days 0
State HI
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia
Symptom Text: Information has been received from a physician concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on approximately 18-JAN-2007 was vaccinated with HPV vaccine (yeast) (lot # not reported) injection, 0.5 ml, in her left upper arm. There was no concomitant medication. On 18-JAN-2007, the patient developed pain and soreness in both sides of her hips. The patient sought medical attention. No lab diagnostic tests were performed. The patient stated that as of 18-JAN-2007, she only feels pain when she touches the side of her hips. At the time of reporting the outcome was unspecified. No other information was provided by the physician. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 795
Days 0
State AL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site induration
Symptom Text: Information has been received from an office manager concerning a 16 year old female who on 21-DEC-2006 was vaccinated in the arm (unspecified) with the first dose of HPV vaccine (yeast). There was no concomitant medication. On approximately 21-DEC-2006, after receiving the vaccination, the patient developed a "knot" at the injection site. The patient sought unspecified medical attention. The "knot" at the patient's injection site persisted. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 796
Days 0
State MI
Mfr Report Id WAES 0701USA03195 Route Intramuscular Intramuscular
Lot Prev Doses U2141AA 0 653938/0954F 0
NO CONDITIONS, NOT SERIOUS Dizziness, Feeling hot
Symptom Text: Information has been received from a registered nurse concerning a 14 year old white female (weight 118#, height 60.75") with otitis, sore throat, congestion, runny nose, amoxicillin and erythromycin allergy who on 22-DEC-2006 was vaccinated with the first dose of HPV vaccine (yeast) (lot # 653938/0954f), IM. Concomitant therapy included MENACTRA (lot # U2141AA), IM. On 22-DEC-2006 after the vaccine while at the check out window, the patient stated that she felt hot, felt her vision was fading and felt faint. The registered nurse held her arm and walked with her back to an exam room where she had her lay down and elevated her legs on two pillows for 15 minutes. The patient's feeling passed. When the patient first returned to the exam room the physician checked her and then checked her when she felt better. After 15 minutes of lying down. Subsequently, the patient recovered from the events that same day. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure, 12/22/06, 98/60, normal otitis; sore throat; nasal congestion; runny nose; penicillin allergy; allergic reaction to antibiotics


Page 797
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Urinary tract infection
Symptom Text: Information has been received from a physician concerning a 14 year old female patient who on approximately 05-JAN-2007 was vaccinated at another physicians office with HPV vaccine (yeast) (lot # not provided). On an unspecified date in January 2007, the patient was seen by the reporting physician for a suspected urinary tract infection (lab results not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 798
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 14 year old female who on 15-JAN-2007 was vaccinated, intramuscularly with the first dose of HPV vaccine (yeast), (lot # not reported). On 15-JAN-2007 the patient fainted after receiving the vaccination. The patient was seen in the Emergency Room (ER) following vaccination and "no problems were found". At the time of the report, it was unspecified, if the patient recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 799
Onset Date Unknown
Days
State IN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Papilloma viral infection
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female with allergy to cefaclor (CECLOR) who on 22-NOV-2006 was vaccinated with the first dose of HPV vaccine (yeast). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING), lansoprazole (PREVACID) and minocycline HCl. On 03-JAN-2007, the patient had a cervical (PAP) smear. The patient tested positive for Papilloma viral infection (HPV). On 11-JAN2007, the patient was vaccinated with the second dose of HPV vaccine (yeast). (Lot # 655617/1447F). The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested. Nuvaring, Prevacid, minocycline hydrochloride Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: cervical smear, 01/03/07 (+), positive for HPV Allergic to antibiotics


Page 800
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injury, Loss of consciousness
Symptom Text: Information has been received from a registered nurse via a company representative concerning a 16 year old female who, "the other night", was vaccinated with a first dose of HPV vaccine (yeast) (lot# not reported). The nurse reported that girl passed out in the office and hit her head after receiving a first dose of vaccine. The girl was unconscious in the office waiting room 3 to 4 minutes. It was reported that the patient was "revived" by using ammonia inhalant, and "seemed to take longer than expected to regain consciousness." The patient was administered an office neurological exam which was "ok and the patient was sent home", reported as recovered. The nurse also reported that it was unclear if this injection was painful. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: neurological, 01/07, comment: "was ok" UNK


Page 801
Days 0
State MI
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female student with emotional issues (in counseling) who on 29-NOV-2006, at 4:00 PM, was vaccinated IM into the left arm with a first dose of HPV vaccine (yeast) (lot# 653938/0954F). There was no illness at the time of vaccination. It was reported that the vaccination was given while the patient was sitting. A few second after the injection, the patient said "oh", and leaned to the right slowly to a reclined position and remained conscious but stiffened. She was awake. The doctor checked on her and stated that she was having a vagal response. After reclining 5-10 minutes, she said she was ok. Her blood pressure was 112/78 and temperature was 100.1F. The nurse noted that the patient was dressed in multiple layers and a hat and she had no had lunch. The patient was considered recovered on the same day, 29-NOV-2006. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure, 11/29/06 112/70; body temp, 11/29/06 100.1f emotional problems


Page 802
Days 2
State IN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Erythema, Flushing, Hot flush, Nausea, Syncope
Symptom Text: Information has been received from a mother of a 16 year old female patient with "cysts in her ovaries", and allergies to penicillin, sulfa, cefaclor (CECLOR) and erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) who on 29-NOV-2006 was vaccinated with HPV vaccine (yeast), "in her hip". There was no concomitant medication. Subsequently, "within 2 to 3 days after receiving the injection." the patient developed "hot flushes", fainted, felt dizzy, and nausea. The patient was also "red and flushed" in her face since receiving the injection. The patient was experiencing the "hot flushes" almost every day. It was also reported that the patient had been vaccinated with Tdap "whooping cough" injection (manufacturer unknown) on 05-JAN-2007 and the patient experienced swelling, itching and "a knot" at the injection site for the last "two to three weeks." At the time of the report, the patient was reportedly not recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE ovarian cyst; penicillin allergy; sulfonamide allergy; drug hypersensitivity


Page 803
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Loss of consciousness, Pain
Symptom Text: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of HPV vaccine (yeast). Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). The nurse reported that there were a total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of HPV vaccine (yeast) out of 130 total doses administered by the office. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 804
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 805
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 806
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female between 15 and 16 year old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 807
Onset Date Unknown
Days
State TN
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 808
Days 0
State --
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site discolouration
Symptom Text: Information has been received from a clinical trial coordinator concerning a female health care worker (age not reported) at a study site. On 04-DEC-2006, the patient was vaccinated in the left deltoid with the first dose of HPV vaccine (yeast) outside of the study. Subsequently, the patient developed discoloration. A band aid was placed over the injection site. As of 12-JAN-2007, there was still obvious discoloration to the area with visible outline of the band aid. The patient stated that she had never had this happen with a band aid before. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 809
Onset Date Unknown
Days
State CO
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site pruritus, Oedema peripheral, Oedema peripheral
Symptom Text: Information has been received from a nurse in a doctor's office concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient's hands and feet swelled and had itchiness at the injection site. The patient refused to come in for the second vaccine. The patient recovered. Unspecified medical attention was sought. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 810
Days 0
State IL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hot flush, Nausea
Symptom Text: Information has been received from a medical assistant concerning a 16 year old female with a penicillin, sulfonamide and cefaclor (CECLOR) allergy who on 29-NOV-2006 was vaccinated with a dose of HPV vaccine (yeast). It was reported that ever since she was given the vaccine, the patient experienced hot flashes and nausea. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK penicillin allergy; sulfonamide allergy; allergic reaction to antibiotics


Page 811
Onset Date Unknown
Days
State WA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Lymphadenopathy, Pain
Symptom Text: Information has been received from a immunization coordinator nurse concerning a 26 year old female nurse in her office who on 18-JAN-2007 was vaccinated in the arm with a second dose of HPV vaccine (yeast). Subsequently the patient experienced "general achiness" throughout her body and swollen lymph glands. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. It was reported that the patient "did not respond like this" after her first dose of HPV vaccine (yeast). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 812
Onset Date Unknown
Days
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Epistaxis
Symptom Text: Information has been received from a nurse concerning her 16 year old daughter who in approximately December 2006, was vaccinated with her first dose of HPV vaccine (yeast). Subsequently, the patient developed three nosebleeds. Medical attention was sought. The patient was recovering. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 813
Days 0
State --
Site Unknown
ER VISIT, NOT SERIOUS Loss of consciousness, Nausea, Vomiting
Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female on contraception, and supplements with iron deficiency anaemia and no allergies, who on 18-JAN-2007 was vaccinated IM with a first dose of HPV vaccine (yeast) (lot# 655165/1425F). Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN) and iron (unspecified). Two hours after, the patient called the office and complained of nausea and vomiting. The patient came into the office the next day because her vomiting lasted throughout the night and she stated that she passed out. By the time she came to the office she was doing better. No diagnostic studies were performed. At the time of this report, the patient was recovered. No product quality complaint was involved. Additional information has been requested. Loestrin, iron (unspecified) Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: contraception; routine health maintenance; iron deficiency anaemia


Page 814
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure decreased, Pallor
Symptom Text: Information has been received from a nurse concerning a 14 year old female who on 23-JAN-2007 was vaccinated with the first dose of HPV vaccine (yeast) (lot number not provided). The nurse reported that after the patient received the vaccination she turned pale "within 10 minutes of vaccination". The nurse reported that the patient's blood pressure was 120/80 prior to vaccination and her blood pressure dropped to 90/50 about ten minutes after the patient was vaccinated. The nurse reported that the patient was sent to the Emergency Room (ER) at the hospital nearby for treatment and observation. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure, 01/23/07, 120/8; blood pressure 01/23/07, 90/50 UNK


Page 815
Days 1
State FL
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Pain of skin, Pruritus, Rash
Symptom Text: Information has been received from an L.P.N. concerning a 13 year old female student with a congenital heart defect and allergy to contrast dye who on the morning of 05-JAN-2007 between approximately 9-11 a.m. was vaccinated in the left upper arm with her second dose of Gardasil (yeast), lot#654389/0961F. In the p.m. of 06-JAN-2007 the patient developed skin tender and some skin "bumps" with pruritis X 2 days. It was reported that on 09-JAN-2007, the patient recovered. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unspecified congenital anomaly of heart; Hypersensitivity UNK


Page 816
Onset Date Unknown
Days
State FL
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (demographics not reported) who on an unspecified date was vaccinated with Gardasil (yeast) (Lot# not provided). Subsequently the patient developed hives. At the time of this report it was unknown if the patient had recovered from the hives. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 817
Days 0
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Vaginal haemorrhage
Symptom Text: Information has been received from two nurses at a physician's office concerning a female (age not reported) who in October 2006 was vaccinated with the first dose of Gardasil (yeast). In October 2006, the patient developed excessive vaginal bleeding (during her period). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 818
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Hypokinesia, Malaise, Pain in extremity, Pyrexia
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil (yeast). Subsequently the patient developed malaise and fever, also had a sore arm such that she felt she couldn't move it for 24 hours. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 819
Days 2
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dyspnoea, Epigastric discomfort
Symptom Text: Information has been received from the father of an 18 year old female with a penicillin allergy noted as rash and fever. On 16-JAN-2007, the patient was vaccinated intramuscularly in the deltoid, with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 18-JAN-2007, the patient developed epigastric pressure and discomfort. On 19-JAN-2007, the patient was examined by her physician and was prescribed famotidine. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information has been requested. PEPCID Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy; Rash; Fever NONE


Page 820
Days 2
State VA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Pruritus
Symptom Text: Information has been received from a physician concerning a 26 year old female who on 19-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil (yeast). On approximately 21-JAN-2007, "within about three days", the patient reported that both her arms were itchy and red. The patient sought unspecified medical attention. The physician reported that she told the patient to take some Benadryl to treat the symptoms. The physician reported that she did not plan to re-vaccinate the patient with Gardasil (yeast). No lot number was provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 821
Days 40
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, Pelvic pain
Symptom Text: Information has been received from a licensed visiting nurse through the pregnancy registry concerning a 18 year old female who became pregnant during the 3-dose of Gardasil (yeast). On 08-NOV-2006, the patient was vaccinated with the first dose of Gardasil (yeast). It was reported that the patient was not pregnant when she received her first dose of Gardasil (yeast). On 18-DEC-2006, the patient developed pelvic pain. The patient was seen in the emergency room. At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) UNK


Page 822
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Rash erythematous, Rash generalised
Symptom Text: Information has been received from a Pharm D healthcare student concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Two weeks post vaccination, the patient developed a full body rash with tiny, erythematous papules. The patient sought unspecified medical attention. The pharmacist stated that the he has no other information, as the nurse had the chart. At the time of this report, the outcome of the event was unknown. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 823
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site swelling
Symptom Text: Information has been received from a physician concerning a 16 year old female who "about 2 months ago" in approximately. November 2006, was vaccinated, intramuscularly (IM), into the deltoid muscle with the first 0.5 ml, dose of Gardasil (yeast). "About 2 months ago". in approximately, November 2006, on the same day of injection, the patient developed swelling at the site of injection. The patient reported that the swelling at the injection site subsided (date not reported). The patient sought unspecified medical attention. The patient received the 2nd dose recently without incident. The latter dose was administered (IM) in the thigh. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 824
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine (yeast). Subsequently, following vaccination, the patient fainted. The patient fully recovered. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 825
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 826
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 827
Days 30
State OR
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS HIV test negative, HIV test positive
Symptom Text: Information has been received from a health professional concerning a 17 year old female who in November 2006, was vaccinated with a first dose of HPV vaccine (yeast). In December 2006, the patient tested positive for human immunodeficiency virus (HIV). The HIV test was performed in December 2006 when the patient donated blood. Unspecified medical attention was sought. The patient had 2 subsequent HIV tests. The first test was "equivocal" and the second test was negative. It was reported that the patient was not sexually active and did not use intravenous (IV) drugs. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: serum HIV-1 gag, 12/06, positive; serum HIV-1 gag, equivocal; serum HIV-1 gag, negative UNK


Page 828
Days 1
State WI
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a 36 year old female with sulfonamide allergy and irritable bowel syndrome who on 11-DEC-2006 was vaccinated with a second 0.5 mL of HPV vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO). In December 2006, " few days after" receiving the vaccination, the patient broke out in hives and a rash on her chest. The patient sought unspecified medical attention. Subsequently, after three weeks, the patient recovered from the hives and rash. It was reported that the patient did not have a reaction after vaccination with the first dose of HPV VLP vaccine (yeast). Additional information has been requested. Lexapro Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE sulfonamide allergy; irritable bowel syndrome


Page 829
Days 4
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Confusional state, Disorientation
Symptom Text: Information has been received from a physician concerning a "15 year 11 months" old female who on 17-JAN-2007 was vaccinated with her first dose of HPV vaccine (yeast). Concomitant therapy included Citalopram hydrobromide (CELEXA). On 21-JAN-2007 the patient was disoriented and confused about her surroundings. The patient was seen in an Emergency Department. Blood work. Computed axial tomography scan (CT) and drug screening were all normal. Additional information has been requested. Celexa Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Diagnostic test: computed axial, 01/21/07, normal; diagnostic laboratory, 01/21/07, normal Lab Results: blood drug screen, 01/21/07, normal UNK


Page 830
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypersensitivity
Symptom Text: Information has been received from a nurse practitioner concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (yeast). Subsequently the patient developed an "allergic reaction". Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 831
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Injection site reaction
Symptom Text: Information has been received from a licensed practical nurse concerning approximately 14 patients who was vaccinated with Gardasil (yeast). Subsequently the patients experienced injection site reaction including pain. The reactions resolved "after a couple of days". Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 832
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female patient who was vaccinated IM with a 0.5 ml "recent" dose of HPV vaccine (yeast). Subsequently the patient called the practice and reported swelling in both arms and she wanted to be seen by the physician. No further information was provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 833
Days 0
State --
Mfr Report Id WAWS 0701USA04282 Route Intramuscular
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Fatigue, Hypertension, Tachycardia
Symptom Text: Information has been received from a physician concerning a 20 year old female with a history of collapse of left lung (September 2006 for which she recovered) who on 05-JAN-2007 was vaccinated with a first IM dose of HPV vaccine (yeast). Concomitant therapy on 05-JAN-2007 included a dose of medroxyprogesterone acetate (DEPO-PROVERA). On 05-JAN-2007 the patient experienced dizziness, tiredness, tachycardia and high blood pressure. The patient has been on medroxyprogesterone acetate since July 2006 and has not experienced any of these symptoms. Her pulse rate has been as high as 145 at rest and blood pressure was 138/85 and an EKG showed tachycardia. Blood work was done and results not provided. She is scheduled to have pulmonary function tests on 07-FEB-2007 and will be seeing a cardiologist "in the future." The patient's dizziness and tiredness and tachycardia and high blood persisted. Additional information has been requested. Depo-Provera Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Diagnostic test: blood pressure, 01/05/07, 138/6; electrocardiogram, 01/05/07, tachy; Lab Results: total heartbeat count, 01/05/07, 145 collapse of lung


Page 834
Onset Date Unknown
Days
State IL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Inappropriate schedule of drug administration, Pruritus, Rash
Symptom Text: Information has been received from a physician concerning a 32 year old female with no pertinent medical history or drug reactions/allergies, who on an unspecified date was vaccinated with Gardasil (yeast) (0.5 ml). There was no concomitant medication. Subsequently, 30 minutes after vaccination, the patient developed redness and itchiness on the palms of her hands, soles of her feet, and in a "band around her waist". The patient also developed "8 red spots on the left side of her truck". The redness, itchiness, and red spots lasted for approximately 5 days and then disappeared. It was reported that nothing occurred at the injection site. Unspecified medical attention was sought. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 835
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (yeast) (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. It was reported that the patient regained consciousness after a "couple of minutes". Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 836
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Heart rate increased
Symptom Text: Information has been received from a nurse practitioner concerning a 14 year old female with no pertinent medical history and no history of drug reactions/allergies in January 2007 was vaccinated with the first dose of Gardasil (yeast) (Lot # not reported) 0.5 ml injection. There was no concomitant medication. In January 2007, the evening she received her first dose of Gardasil (yeast), she experienced rapid heart beat. Medical attention was sought. She had the same experience 24 hours later. The patient has not had another experience since then. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 837
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a couple of females with unspecified pertinent medical history and unspecified drug reactions/allergies who on an unspecified date were vaccinated with first dose of Gardasil (yeast) (lot # not reported), 0.5 ml, IM. Concomitant therapy was not specified. On an unspecified date, the patients experienced tingling in their fingers of the arm being injected while getting the injection. The tingling resolved within a couple of minutes of receiving the shot. Medical attention was sought. At the time of reporting, the patients had recovered. The patients plan on getting was sought. At the time of reporting, the patients had recovered. The patients plan on getting their second and third doses of Gardasil (yeast). Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 838
Days 0
State MI
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Pruritus generalised
Symptom Text: Information has been received from a physician concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of Gardasil (yeast) 0.5 ml IM. On 18-JAN-2007, the patient was vaccinated with a second dose of Gardasil (yeast) (lot # not reported). Concomitant therapy included SYNTHROID and LO/OVRAL. On 18-JAN-2007, fourtyfive minutes after receiving the second dose, the patient experienced generalized itching. No additional symptoms were noticed. Medical attention was sought. The physician prescribed BENADRYL and the symptoms resolved. The patient fully recovered on 18-JAN-2007. No further information was available at the time of reporting. Additional information has been requested. LO/OVRAL, SYNTHROID Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Papanicolaou smear abnormal Hypothyroidism


Page 839
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Vaccine positive rechallenge, Vertigo
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female with no medical history who in October 2006 or November 2006 was vaccinated with her second dose of HPV VLP vaccine (yeast) (0.5 mg), intramuscularly. There was no concomitant medication. Subsequently, the patient experienced intermittent vertigo 5 days later. The patient was "recently" administered her third dose of HPV VLP vaccine and was "now" experiencing constant vertigo. It was noted that the patient had a family history of vertigo. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 840
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Meningism, Musculoskeletal stiffness
Symptom Text: Information has been received from a nurse concerning a 17 year old female who at the "end of December" was vaccinated with a second dose of HPV VLP vaccine (yeast) (0.5 ml). Subsequently, the patient experienced meningitis like symptoms and cervical neck stiffening. Unspecified medical attention was sought. At the time of the report, th patient was recovering. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 841
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a laboratory technician concerning a 26 year old female who on 15-JAN-2007 was vaccinated with a first dose of HPV vaccine (yeast). Ten minutes after the vaccination, the patient passed out at the check out for an unspecified time. The patient said that she always passes out after she gets an injection. Unspecified medical attention was sought. On 15-JAN-2007, the patient recovered without incident. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK loss of consciousness


Page 842
Days 0
State TX
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injected limb mobility decreased, Paraesthesia, Skin discolouration, Skin warm
Symptom Text: Information has been received from a registered nurse concerning her 22 year old daughter with no allergies who on 24-JAN-2007 was vaccinated with HPV VLP vaccine (yeast). Concomitant therapy included methylphenidate HCl (RITALIN) and "pregnancy shot" (name unknown). On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot." Later that evening her "fingers turned white and blue." She then went back to the physician who instructed her to "wrap it in warm packs." The patient also took diphenhydramine HCl (BENADRYL). The nurse stated that her daughter's arm was getting better, but she still had trouble picking up her arm to her shoulder area. At the time of the report, the patient was recovering. Additional information has been requested. therapy unspecified, Ritalin Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 843
Days 0
State --
Prev Doses
Symptom Text: Information has been received from a consumer concerning a 38 year old female with sulfa allergy who "about two months ago" in approximately November 2006 was vaccinated with HPV VLP vaccine (yeast). There was no concomitant medication. Subsequently, "about two months ago" in approximately November 2006, the patient experienced "swelling in upper left arm where the (HPV vaccine) was administered." The site was immediately sore. The swelling increased at first and subsided after about a month. Unspecified medical attention was sought. The patient recovered "about one month ago." There were no relevant diagnostic tests or laboratory data. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE sulfonamide allergy


Page 844
Onset Date Unknown
Days
State TX
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Injection site erythema, Injection site induration, Nerve injury
Symptom Text: Information has been received from a nurse concerning a 19 year old female who, on an unspecified date, was vaccinated intramuscularly with a second dose of HPV VLP vaccine (yeast). The patient developed immediate redness at the injection site and a knot was noticed at the injection site 1 to 2 days post injection. The nurse reported that the patient did not see her family physician and the family physician suspected "nerve damage." It was not specified whether or not the patient had a reaction the first time she was vaccinated with HPV VLP vaccine (yeast). The nurse reported that they were following up with the patient to make sure she was okay. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 845
Days 0
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning his 15 year old daughter who on 03-JAN-2007 was vaccinated with a first dose of HPV VLP vaccine (yeast). On 03-JAN-2007 the patient fainted and experienced soreness at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 846
Days 0
State MA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV VLP vaccine (yeast). After vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 847
Vaers Id: 272569-1 Age Gender F 13.0 VAX Detail: Type TDAP FLUN HPV4 Seriousness: MedDRA PT
Days 2
Received Date 19-Feb-2007 Lot NULL 500438P 0960F
State NH
Manufacturer GLAXOSMITHKLINE BIOLOGICALS MEDIMMUNE, INC. MERCK & CO. INC.
Prev Doses
NO CONDITIONS, NOT SERIOUS Vaginal haemorrhage
Symptom Text: pt recieved HPV #1 on 1/25/07 since vaccine has had period for past 22 days. has not had issues with vaginal bleeding between period before vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: will be getting tsh, ferritin, and cbc


Page 848
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Mass, Tenderness
Symptom Text: Information has been received from a 25 year old female office manager who on 13-DEC-2006 was vaccinated with a first 0.5 mL dose of HPV VLP vaccine (yeast). On 13-DEC-2006, the patient developed a small bump under the skin that was tender after receiving the vaccination. The patient sought unspecified medical attention. At the time of this report, the patient's small, tender bump under the skin persisted. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 849
Days 0
State WA
Site Unknown
ER VISIT, NOT SERIOUS Headache, Pharyngeal hypoaesthesia, Throat tightness
Symptom Text: Information has been received from a registered nurse concerning a 20 year old female with an allergy to amoxicillin (AUGMENTIN) who on 29-NOV-2006 was vaccinated IM, into the deltoid, with a first dose of HPV VLP vaccine (yeast) (lot # 654540/0800F). Concomitant therapy included ORTHO EVRA. Approximately 1 minute after the vaccination, the patient reported that her "throat felt constricted." Subsequently, the patient recovered after 5 minutes. On 25-JAN-2007 the patient was vaccinated with a second dose of dose of HPV VLP vaccine (yeast). Five seconds after the vaccination, the patient experienced "numbness in the throat" that lasted a short duration. The patient reported that she developed an intense headache 30 minutes after the vaccination that lasted until she went to bed. On 26-JAN-2007, the patient recovered from the headache. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. Additional information has been requested. Ortho Evra Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK drug hypersensitivity


Page 850
Onset Date Unknown
Days
State WI
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy
Symptom Text: Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 23 year old female with allergies to sulfamethoxazole (+) trimethoprim (BACTRIM) and nitrofurantoin (MACROBID) high blood pressure but no current blood pressure medication. Rhesus antibodies (RH) negative, and a history of cervical dysplasia, urinary tract infections and Caesarian (C) section for first child, year 2006, who on 25-AUG-2006 was vaccinated with HPV vaccine (yeast). The nurse reported that the patient was scheduled for a leep procedure, due to cervical dysplasia on 20-SEP-2006 and before the procedure a blood serum pregnancy test was taken, and result was positive for pregnancy. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: serum beta-human, 09/20/06, (+), positive for pregnancy Cervical dysplasia, Caesarean section; Urinary tract infection; blood pressure high, sulfonamide allergy, drug hypersensitivity pregnancy


Page 851
Onset Date Unknown
Days
State GA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Anxiety, Syncope
Symptom Text: Information has been received from a physician concerning a 15 year old female who approximately 18-JAN-2007 was vaccinated by injection with a 0.5 mL dose of HPV vaccine (yeast). Lot # unspecified by reporter). There was no concomitant medication. Subsequently, it was reported that five minutes after the injection the patient fainted. The patient was taken to the emergency room (ER) but no admitted to the hospital. The physician did not think the HPV vaccine (yeast) caused the patient to faint, as much as severe anxiety from the shot. At the time of the report, the patient had recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 852
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV vaccine (yeast). Subsequently, the patient fainted. Her outcome was not reported. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 853
Onset Date Unknown
Days
State WA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Herpes zoster, Urticaria
Symptom Text: Information has been received from a nurse practitioner concerning an 18 year old female patient who was vaccinated with her first dose of HPV vaccine (yeast) and had no adverse side effects. Subsequently, she was vaccinated with her 2nd dose of HPV vaccine (yeast) and within 24 hours broke out in hives, which developed into shingles. Medical attention was sought. As of the report date, the patient was recovering. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 854
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an approximately 23 year old female who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she had another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm she the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 855
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Bone pain
Symptom Text: Information has been received from a pharmacist concerning a 20 year old female who on 25-JAN-2007 was vaccinated with a second dose of HPV vaccine (yeast) 0.5 ml intramuscularly. Subsequently the patient experienced joint and bone pain. The patient sought unspecified medical attention. The patient is recovering from joint and bone pain. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 856
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site cyst
Symptom Text: Information has been received from a registered nurse concerning an "18 or 19" year old female who on 19-JAN-2007 was vaccinated with the first dose of HPV vaccine (yeast). On 19-JAN-2007, the patient developed a cyst at the injection site. The patient sought unspecified medical attention. The patient was referred to a dermatologist. At the time of this report, the outcome of the event was unknown. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 857
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse concerning approximately 75 female patients who were vaccinated IM with 0.5ml doses of Gardasil. Subsequently the patients experienced pain at the injection site. Unspecified medical attention was sought. Subsequently, the patients recovered. Attempts are being made to obtain additional identifying information regarding the patients mentioned in this report. Additional information will be provided when available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 858
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine. Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the tiem of this report, the patient has recovered from the event (date unknown). the nurse reported that there were total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of Gardasil out of 130 total doses administered by the office. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 859
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the time of this report, the patient has recovered from the event (date unknown). The nurse reported that there were total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of Gardasil out of 130 total doses administered by the office. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 860
Onset Date Unknown
Days
State CA
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who on an unspecified date was vaccainted intramuscularly with the second dose of Gardasil. Subsequently, following the second vaccination, the patient experienced irregular periods. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 861
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Vaginal haemorrhage
Symptom Text: Information has been received from two nurses at a physician's office concerning one of the nurses' daughter (age not reported). On an unspecified date, the patient was vaccinated with the first dose of Gardasil. Subsequently, the patient developed excessive vaginal bleeding (during her period). At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 862
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Fungal infection, Immune system disorder, Pharyngolaryngeal pain, Rash, Sinusitis
Symptom Text: Information has been received from a physician concerning a female (age not reported) on approximately 15-JAN-2007 was vaccinated with Gardasil. Subsequently, the patient developed a weakened immune system, yeast infection, sore throat, sinusitis and had a rash on her leg that was lasting several days. At the time of this report, the outcome of the events were unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 863
Days -4
State GA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 21 year old female on antibiotics for condition unspecified, and pertinent medical history and drug reactions/allergies unspecified who on approximately 29-JAN-2007 was vaccinated with first dose of Gardasil (lot # not reported) IM. Concomitant suspect therapy included Antimicrobial (unspecified). The physician reported that the patient sought medical attention (called the office) to report that she had hives (on approximately 25-JAN-2007). The patient had been on antibiotics for a couple of days prior to receiving Gardasil. The physician felt the hives may be related more to the antibiotics than the vaccine. The outcome of the hives was unspecified. no further information was available at the time of reporting. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 864
Days 3
State KY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a certified medical assistant concerning a 21 year old female with penicillin allergy who on 25-JAN-2007 was vaccinated with first dose of Gardasil (lot #654702/0011U), 0.5 ml IM in the deltoid. Concomitant therapy included Yasmin and Wellbutrin. On 28-JAN-2007, three days later, the patient woke up with a rash on her entire body. The patient sought medical attention. The patient took Benadryl, but it had not improved. The medical assistant reported that the patient stated the rash is the same over her entire body, the injection site is not any worse than the rest of her body. At the time of reporting, the patient's rash persisted. No further information was available at the time of reporting. Additional information has been requested. Yasmin, Wellbutrin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Penicillin allergy.


Page 865
Days 11
State NY
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no known adverse drug reactions or allergies reported. On 16-JAN-2007, the patient was vaccinated with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 27JAN--2007, the patient developed a rash on her arms and legs. At the time of this report, the outcome of the event was unknown. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 866
Days 15
Received Date 15-Feb-2007 Lot NULL NULL
State IN
Prev Doses 0
ER VISIT, NOT SERIOUS Erythema nodosum
Symptom Text: information has been received from a physician concerning a 17 year old female with amenorrhea, hirsutism and a CECLOR allergy who on 01-DEC-2006 was vaccinated IM with a first dose of Gardasil (yeast). The patient received Menactra concomitantly. Other concomitant therapy included Ovcon 50. On 16-DEC2006 the patient developed erythema nodosum. The patient sought unspecified medical attention. The patient was treated with a course of steroids and has fully recovered. No laboratory diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested. OVCON 50 Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Amenorrhea, Hirsutism, Allergic reaction to antibiotics


Page 867
Days 10
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning his 20 year old female daughter with no other pertinent medical history reported. On 18-JAN-2007, the patient was vaccinated IM with the first 0.5 ml dose of Gardasil (yeast). There were no concomitant medications reported. On 28-JAN-2007, the patient developed unilateral supraclavicular lympadenopathy. There were no other symptoms reported. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 868
Days 2
State GA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a dose of Gardasil (yeast). On 27-JAN2007 the patient developed a rash on her arm, chest and back. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 869
Days 0
State SD
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Malaise, Nausea
Symptom Text: Information has been received from a healthcare provider concerning her 20 year old daughter with a penicillin allergy who on 29-JAN-2007, in the morning, was vaccinated with a second IM dose of Gardasil (yeast). Concomitant therapy included Ortho Tri Cyclen, Advair. On 29-JAN-2007 "later in the day" the patient was driving and developed dizziness and nausea. She could no longer drive so the passenger took over driving. As of 29-JAN-2007 she still did not feel well when she got back to school. A first dose of Gardasil (yeast) was given IM on 22-NOV-2006. Additional information has been requested. albuterol, ORTHO TRI-CYCLEN, ADVAIR Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Ovarian cyst, Asthma Penicillin allergy


Page 870
Days 18
State PA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Dyspnoea, Muscle spasms, Vaginal haemorrhage
Symptom Text: Information has been received from a 22 year old female certified medical assistant who on 12-SEP-2006 was vaccinated IM with the first dose of Gardasil (yeast) (Lot#653735/0688F). On 13-NOV-2006 the patient received the second dose of Gardasil (yeast) (Lot#653735/0688F). Concomitant therapy included Depo-Provera. On an unspecified date in December 2006, the patient began with vaginal bleeding "on and off for several weeks. On 13-JAN-2007 the patient started with a flow that was very heavy lasting seven days, with cramping and shortness of breath. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested. DEPO-PROVERA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 871
Days 0
State VA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies unspecified who on approximately 18-JAN-2007 was vaccinated with Gardasil (yeast) (lot # not reported). On approximately 18-JAN-2007, the patient experienced a rash all over her body. The outcome of the rash was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 872
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Disturbance in attention, Feeling abnormal
Symptom Text: Information has been received from a 23 year old female emergency medical attention with a penicillin allergy who on 29-JAN-2007 was vaccinated IM with a second 0.5 ml dose of Gardasil (yeast). On 29-JAN-2007 the patient reported feeling "weird or slow in the head" and "can not concentrate or think clearly". The patient received a first IM 0.5 dose of Gardasil (yeast) on 12-DEC-2006. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 873
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a pharmacist concerning a 10 year old female vaccinated with a first 0.5 ml dose of Gardasil (yeast). Two days later, the patient developed a rash behind her knees and on her chest. Unspecified medical attention was sought. At the time eof this report, the patient's outcome was unknown. No product quality was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 874
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female, pediatric patient who was vaccinated with Gardasil (yeast), (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 875
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dry mouth
Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with Gardasil (yeast). Subsequently the patient experienced dry mouth. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 876
Days 29
State PA
Last Edit Date 21-Feb-2007 Other Vaccine VARCEL
Site Unknown
NO CONDITIONS, NOT SERIOUS Dysmenorrhoea, Dyspnoea, Groin pain, Menorrhagia
Symptom Text: Information has been received from a health professional concerning a 12 year old white female who on 28-DEC-2006 was vaccinated intramuscularly with the first dose of HPV vaccine (yeast) (lot# 653735/0688F). Concomitant therapy included varicella virus vaccine live (MSD) received on 08-DEC-2006 and Menactra vaccine received on 27-NOV-2006. On approximately 26-JAN-2007 the patient experienced an extremely heavy menstrual cycle with more cramps than previous cycles, one episode of pain in the groin area and shortness of breath while at basketball practice. At the time of this report it was unknown if the patient had recovered from these events. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 877
Days 2
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site erythema, Injection site induration, Injection site swelling
Symptom Text: Information has been received from a nurse concerning a female with diabetes who on 26-JAN-2007 was vaccinated with the second dose of Gardasil (yeast). On 28-JAN-2007 the patient experienced a big knot, redness and puffiness at the injection site. The patient sought medical attention. The patient is recovering from a big knot, redness and puffiness at the injection site. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Diabetes


Page 878
Days 0
State RI
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dyspnoea, Nausea, Panic attack, Vomiting
Symptom Text: Information has been received from a Certified Nurse Midwife concerning a 20 year old female who is "prone to panic attacks" who on 29-JAN-2007 at 11:15 am was vaccinated IM with the first dose of Gardasil (yeast) (Lot # not provided). At 7:30 pm that same evening the patient experienced a panic attack with severe nausea, vomiting and difficulty breathing and went to the emergency room. The patient was not admitted to the hospital. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Panic attack


Page 879
Onset Date Unknown
Days
State WA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Pain in extremity
Symptom Text: Information has been received from a receptionist at a physician's office concerning a 23 year old female who "about a month ago" in approximately December 2006 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed a sore arm. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 880
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a first dose of Gardasil (yeast). On 26JAN-2007 the patient experienced itching and a rash around the area of the arm and the back of the knee. The rash continued to worsen and medication was ordered to treat the rash. At the time of this report, the patient's outcome was unknown. It was noted that the patient will not receive the second and third dose of the vaccine. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 881
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 2 of 4) who was vaccinated with Gardasil (yeast). The registered nurse reported that she another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 882
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 3 of 4) who was vaccinated with Gardasil. The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved ant the patient was sent home. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 883
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 4 of 4) who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 884
Days 0
State MA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). After vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 885
Days 0
State MA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). After vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 886
Days 7
State NY
Site Unknown
ER VISIT, NOT SERIOUS Injection site erythema, Injection site pain
Symptom Text: Information has been received from a physician concerning a 15 year old female with no past medical history who on 22-JAN-2007 was vaccinated IM with a second 0.5 ml dose of HPV vaccine (yeast) (lot #655617/1447F). There was no concomitant medication. On 29-JAN-2007 the patient developed erythema and mild tenderness at the site of injection. There was no fever. She sought unspecified medical attention. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 887
Days 10
State MA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Lymph node pain, Malaise
Symptom Text: Information has been received from a physician concerning an approximately 20 year old female, with no medical history, who on 11-JAN-2007 was vaccinated intramuscularly with a first dose of HPV vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 21-JAN-2006 the patient developed bilateral tender lymph nodes and malaise. Unspecified medical attention was sought. At the time of the report, the patient's bilateral tender lymph nodes and malaise persisted. There were no laboratory or diagnostic tests performed. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 888
Days 3
State --
Lot Prev Doses 654702/0011U 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 19 year old female who on 23-JAN-2007 was vaccinated with a 0.5 ml first dose Gardasil (lot #654702/011U). On 26-JAN-2007 the patient developed a rash on her stomach. Medical attention was sought and the patient was told to take diphenhydramine hydrochloride (BENADRYL). There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered from rash on her stomach. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 889
Days 1
State PA
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Pain in extremity, Paraesthesia
Symptom Text: Information has been received from a registered nurse from a hospital infusion center concerning a 22 year old female with sulfa allergy and no pertinent medical history who on 26-JAN-2007 was vaccinated with first dose of Gardasil (lot# 655619/1427F), 0.5 ml, IM in left deltoid. There was no concomitant medication. On 27-JAN-2007, Saturday morning, the patient called and reported she experienced pain at the injection site and the pain had increased. The patient sought medical attention. No diagnostic tests were performed. On 31-JAN-2007, the patient experienced pain and tingling down her left arm. At the time of reporting, the patient had no recovered. The patient was referred to her primary physician for follow-up. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE sulfonamide allergy


Page 890
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Injection site erythema, Paraesthesia
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as unspecified who on 28-JAN-2007 was vaccinated with Gardasil (lot# not reported), 0.5 ml IM. Concomitant therapy was unspecified. On approximately 28-JAN-2007, the patient experienced redness at the injection site with tingling in her arms. The condition progressed to tingling in her fingers with numbness in both arms and fingers. The patient sought medical attention. At time of reporting, the patient had not recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 891
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a consumer concerning her 19 year old daughter who on approximately 17-JAN-2006 was vaccinated with a dose of Gardasil. Subsequently the patient developed a "rash from head to toe." It was reported that the patient had followed up with her physician. At the tiem of the report, the patient's rash persisted. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 892
Onset Date Unknown
Days
State MD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Injection site pain, Similar reaction on previous exposure to drug
Symptom Text: Information has been received from a nurse practitioner concerning a 21 year old female who on unspecified dates was vaccinated intramuscularly with the first and second doses of Gardasil. Subsequently, the patient experienced dizziness and injection site stinging following the first vaccination and injection site stinging following the second vaccination. It was reported that the events occurred immediately after vaccination and resolved after about 5 minutes. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 893
Onset Date Unknown
Days
State MD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site pain, Loss of consciousness
Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included a tetanus toxoid shot. Immediately with vaccination, the patient developed injection site stinging and the patient passed out for a few seconds. The patient sought unspecified medical attention. The nurse practitioner reported that the patient was fine after a few seconds and was able to drive home. Thee was no lot number provided. Additional information has been requested. Tetanus toxoid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 894
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Nervous system disorder, Pain in extremity
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated, intramuscularly with HPV vaccine. The nurse reported that the patient was having "neurological problems" after receiving the vaccine. The reporter stated that the patient explained she was having "pain and numbness" in her extremities. The reporter stated the patient was going to see a neurologist. At the time eof the report, it was unknown, if the patient recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 895
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following vaccination, the patient fainted. The patient fully recovered. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 896
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following vaccination, the patient fainted. The patient fully recovered. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 897
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient who on unspecified dates was vaccinated with the first and second doses of HPV vaccine. Subsequently, following each vaccination, the patient vomited. The patient fully recovered. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 898
Days 2
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pain, Skin lesion
Symptom Text: Information has been received from a physician concerning a female patient who on 12-JAN-2007 was vaccinated with a dose of HPV vaccine. On 14-JAN2007 the patient experienced painful raised lesions on the arm where the vaccine was administered. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 899
Days 2
State CA
Site Unknown
ER VISIT, NOT SERIOUS Rash, Skin lesion
Symptom Text: Information has been received from a physician concerning a 25 year old female who on 12-JAN-2007 was vaccinated IM in the right deltoid, with a first 0.5 ml dose of HPV vaccine (lot#655619/1427F). There was no concomitant medication. On 14-JAN-2007 the patient developed skin eruptions, lesions, on the axilla of the right arm. It was reported that the patient was treated with Benadryl. The patient reported the patient's lesions continued for two weeks and were worsening. At the time of the report, the patient had not recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 900
Days 0
State TX
Prev Doses 0
ER VISIT, NOT SERIOUS Drug administered at inappropriate site, Injection site rash, Rash
Symptom Text: Information has been received from the mother of a 22 year old female, via a consumer (friend), who on approximately 24-JAN-2007 was vaccinated in the buttock with the first dose of HPV vaccine. On approximately 24-JAN-2007 the patient developed an initial rash at the injection site, which went away. A few days later, approximately 27-JAN-2007 the patient developed a rash on her entire trunk, spreading form her crotch to her shoulders. The patient's mother was thought to be a nurse, who administered the injection to her daughter at home after she picked up the vaccine from her daughter's physician. It was also reported that the mother of the patient had picture of her daughter's rash. At the time of the report the patient had not recovered from the rash on her trunk. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 901
Days 1
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on 30-JAN-2007 was vaccinated with the second 0.5 mL dose of HPV vaccine. Concomitant therapy included unspecified hormonal contraceptives. On 31-JAN-2007, the patient developed a rash under skin that covered entire body except her legs. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. The nurse did mention that the patient "did not have a reaction to the first injection of HPV vaccine. Additional information has been requested. hormonal contraceptive Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 902
Days 0
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a 22 year old female healthcare worker who on 26-JAN-2007 was vaccinated with HPV vaccine. The patient stated that the "HPV stung a lot as it was being administered." Unspecified medical attention was sought. The patient recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 903
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated by HPV vaccine, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sough unspecified medical attention. Additional information has been requested UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 904
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injections. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 905
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 906
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown


Page 907
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown


Page 908
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown


Page 909
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the tiem of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 910
Onset Date Unknown
Days
State NJ
Prev Doses
Site Unknown


Page 911
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sough unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 912
Days 0
State FR
Mfr Report Id WAES0612AUS00040 Route Intramuscular
Prev Doses
Site Unknown
LIFE THREATENING, SERIOUS Bronchospasm, Dizziness, Dizziness, Dyspnoea, Oxygen supplementation, Pallor, Palpitations, Syncope
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 29-OCT-2006 was vaccinated with Gardasil (lot No 654672/0444F, batch no NE01680, Expiry date 23-FEB-2009) on her left deltoid muscle. The patient is needle phobic and had nothing to eat on 29-OCT-2006 until the patient received vaccination on 12:02pm. On 29-OCT-2006 the patient experienced syncope and bronchospasm. Four minutes after injection, the patient had syncope. The symptoms included light headedness, pallor, feeling like fainting and palpitation. The patient had no chest pain but had bronchospasm with dyspnoea. The patient's sitting blood pressure was 110/67 mmHg and pulse rate was 55. Glasgow Coma Score was 15/15. The patient had oxygen mask. The patient was not hospitalized. The physician considered her diagnosis as phobia, syncope vs drug reaction. Subsequently the patient recovered from syncope and bronchospasm. The physician considered syncope and bronchospasm were related to therapy with Gardasil and asked the patient to reconsider about continuing the next dose of Gardasil. Syncope and bronchospasm were considered to be life threatening by the reporting physician. Additional information is not expected. UNK Other Meds: blood pressure 29Oct06 110/67 mmHg Comment: sitting BP, physical examination 29Oct06 Comment: Pulse rate 55, Glasgow come scale 29Oct06 Comment: Lab Data: 15/15 History: Prex Illness: Prex Vax Illns: Phobic anxiety


Page 913
Vaers Id: 272720-1 (S) Age Gender Vaccine Date F 01-Feb-2007 13.0 VAX Detail: Type HPV4
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Contusion, Haemorrhage, Rectal haemorrhage
Symptom Text: Information has been received from a health professional concerning her 13 year old female cousin with pertinent medical history and drug reactions/allergies not specified who in approximately February 2007, was vaccinated with Gardasil (Lot # not reported) 0.5 ml. Concomitant therapy was unspecified. In approximately February 2007, the patient experienced "internal bleeding throughout her body" after being vaccinated with Gardasil. The bleeding presented initially as bruising and most recently as rectal bleeding. Medical attention was sought. On an unspecified date, the patient was hospitalized. At the time of reporting, the patient had not recovered. The patient's internal bleeding, bruising, and rectal bleeding were reported as immediately life threatening and disabling events No further information was available at the tiem of reporting. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 914
Related reports: 272739-2 Vaccine Date Onset Date 10-Feb-2007 11-Feb-2007 Manufacturer MERCK & CO. INC.
Days 1
State PA
Prev Doses 1
Site Unknown
Symptom Text: Nausea and vomiting 4:30 am 2-11-07 to 5:00 pm Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE high Fever~DTaP (unknown mfr)~2~0~In Patient


Page 915
Days
Received Date 09-Apr-2007 Lot NULL
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female who was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient vomited the day after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sought medical attention. Subsequently, the patient recovered. Additional information is not expected. unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: unknown


Page 916
Days 0
State KY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Hyperaesthesia, Pruritus, Urticaria
Symptom Text: Generalized itching started the evening of vaccine. Increased in sensitivity, esp in scalp over next 3 days. Broke out in hives 3 days after vaccine-both arms and face. Given po Benadryl with improvement. Hives gone after 2 doses of Benadryl. Rx for Zyrtec started. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 917
Days 2
State FL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Rash erythematous, Rash papular, Rash pruritic
Symptom Text: AFEBRILE ERYTHEMATOUS FINE PAPULAR PRURITIC RASH ON CHEST, LEGS, BACK AND ABDOMEN BEGINNING 2 DAYS POST VACCINATION. PRURITITS AND ERYTHEMA RESPONDED TO ORAL BENADRYL. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: THROAT CULTURE TO RULE OUT STREP PN 2/13/07. RESULTS WERE NEGATIVE NONE NONE


Page 918
Days 0
Received Date 21-Feb-2007 Lot 0942R C2644AA 0954F
State PA
Type VARCEL TDAP HPV4
Prev Doses 1 0 0
NO CONDITIONS, NOT SERIOUS Dizziness, Dizziness, Loss of consciousness, Syncope
Symptom Text: 5 minutes after Pt received vaccines, fainted LOC lasted about 5 seconds then pt dizzy and lightheaded for about 5-10 min and relieved by 10 min resting supine then 5 min sitting and drinking gatorade/eating cheese crackers. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Keartosis Pilaris NONE


Page 919
Days 0
State ME
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Dysstasia, Feeling drunk, Incoherent, Lethargy
Symptom Text: Information has been received from a licensed practical nurse concerning an 18 year old female with a penicillin allergy and allergy to BENADRYL who on 11FEB-2007 was vaccinated at another practice with a first dose of Gardasil. There was no concomitant medication. On 11-FEB-2007, 30 minutes after the vaccination, the patient "felt lethargic and could not stand on her own". "She looked like she was drunk and she did not make any sense when she spoke". The patient went to an emergency department and was released. She was reported to have no rash or breathing problems. It was also reported that a urinalysis was clear and drug test was normal. She was reported to have recovered 12 hours after the vaccination./ The reporter felt that the patient's symptoms were disabling. Additional information has been requested. NONE Other Meds: urinalysis 02/11/07 clear, urine drug screen 02/11/07 normal Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy, Drug hypersensitivity


Page 920
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, Foetal disorder, Pregnancy
Symptom Text: Information has been received from a medical assistant concerning her 18 year old daughter with family history free from abnormalities who in August 2006, was vaccinated with Gardasil (lot # not reported) injection, IM. Concomitant therapy included varicella virus vaccine live (lot # not reported) given in September 2006). The patient sought medical attention. At the time of reporting, the patient was 4 months pregnant (estimated last menstrual period 03-NOV-2006 and estimated date of delivery 10-AUG-2007). Her unborn child has fetal abnormalities which were detected shortly after vaccination with Gardasil and varicella virus vaccine live. On an unspecified date, the patient had ultrasounds and amniocentesis performed. Additional information was received from the patient's mother via telephone call who reported that her daughter is currently under the care of perinatologist. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 11/3/2006) Amniocentesis, Ultrasound


Page 921
Days 1
State CA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Dizziness, Nausea, Tremor
Symptom Text: Pt received Gardasil on Feb 5 2007 in pm. She went home the next day she woke up 6:00 am with dizziness, legs shaking, nauseated, feeling faint lasting 3 days unable to go to school. The fourth day she felt better. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE came in for lump on stomach, was hit while playing basketball


Page 922
Days 3
State CO
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Injection site pain, Injection site rash, Urticaria
Symptom Text: HPV vaccine given 2/15/07. PT called office 2/20/07 with reports of "breaking out from vaccine". States on 2/18 she had hives on waist up, dry and flaky. Only "pain and pimple" at injection site (R arm). Pt denied any other changes in detergents, soap, food, perfume, lotion, etc. Pt told to take Benadryl. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Routine Pap smear


Page 923
Onset Date Unknown
Days
Received Date 21-Feb-2007 Lot 1301F U2272AA 1208F
Status Date 22-Feb-2007 Site Left arm Left arm Left arm
State KS
Type VARCEL FLU HPV4
Prev Doses 1 0 1
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration
Symptom Text: The HPV vaccine was given to a 7 yr. old girl. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 924
Days 1
State MI
Prev Doses 0
Site Unknown
Symptom Text: Vaginal bleeding started day after receiving Gardasil vaccine. Bleeding is persistent (Moderate-severe) and still present LMP 12/28/02 ended 01/02/07. Onset menses 10 year age. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Denies sexual activity, PG test neg.


Page 925
Days 0
State --
Prev Doses
NO CONDITIONS, NOT SERIOUS Burning sensation, Incorrect dose administered, Injection site erythema, Injection site pain, Injection site rash, Vaccination complication
Symptom Text: Patient received partial dose of vaccine in left deltoid due to defective syringe. Pt immediately complained of a burning sensation on her arm where the medication ran (down her arm) I cleansed her entire upper arm with alcohol-pt relieved little relief. The she stated it was sore at about a 2 inch radius from the injection site. Pt was discharged in mother's care to monitor her. Pt's mother was contacted around 10:00 am the next day-stated-evening of 02/08/07, pt had severe pain at site and gave 2 500mg doses of Acetaminophen to relieve pain. Mother stated site looked red and raised-similar to a bee sting reaction. She also stated it was gone upon waking and pt now only complaining of moderate site pain with little swelling and redness. Pt to return in 3 days for reevaluation. Ortho-tricyclen, Synthroid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE egg allergy


Page 926
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female with penicillin allergy who on 12-FEB-2007 was vaccinated with Gardasil 0.5ml intramuscularly (lot number 653736/0014U). There was no concomitant medication. On 12-FEB-2007, 45 to 60 minutes post vaccination, the patient called the physician's office stating that she had hives on her arms and legs. The treatment was Benadryl. On 13-FEB-2007, the patient was seen at the physician's office and still had hives on her arms and legs but no shortness of breath. No other treatment was given. The hives were improving. Hives on arms and legs were considered an other important medical event. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy NONE


Page 927
Days 12
Received Date 22-Feb-2007 Lot 1046F 1427F
State PA
Type VARCEL HPV4
Prev Doses 1 0
NO CONDITIONS, NOT SERIOUS Papilloedema, Rash generalised, Varicella
Symptom Text: This was a second varicella immunization. She received her first 6/9/97. She recieved both varicella and Gardacil on 1/17/07 about 10 days later she developed a rash consistant with varicella. The rash was over her entire body with greater than 20 sites. The rash followed the course of varicella and has dried up. She also developed papilledema and needed to be placed on prednisone by an opthalmologist. The rash is resolving but she is still being treated for papilledema by another physician Asmanex, Nasonex, albuterol inhaler, Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: allergies, asthma, Eczema None


Page 928
Days 0
State MD
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Arrhythmia, Dyspnoea, Dysstasia, Fall, Feeling hot, Fluid replacement, Hyperhidrosis, Hyperventilation, Injury, Loss of consciousness, Nausea, Paraesthesia
Symptom Text: I received the vaccination at approximately 8:20 AM and felt nothing (my arm slightly ached where the vaccine had been injected, but I felt nothing out of the ordinary post-injection). I walked over to the check-in counter to schedule my third a final injection in the series and put on my jacket. I remember the nurse saying 8:00 AM on Wednesday, June 20 and then the next thing I remember is being surrounded by people on the floor of the office. I blacked out while standing up and hit the left side of my body (mainly my lower jaw, neck, and clavicle) and when my body hit the floor the center, back of my head slammed to the floor. No one actually saw what parts of my body hit where during the fall because the nurse was behind the counter sitting at the computer (below eyesight of my fall) and patients in the waiting room were seated behind a wall. Based on where I remember standing before blacking out and where my body hurt after waking up, I think I am pretty certain I know what was hit. After waking up the doctor and several nurses helped me sit up and recommended calling an ambulance to have my head checked out. At first I declined because I did not think I had any serious problems, but after I tried standing and could not, I agreed to the ambulance. My face was tingly, I had trouble breathing (when I first woke up I was hyperventilating), I was sweating, and my legs were not stable. The EMT arrived and took my blood pressure and decided I should go to the emergency room for a check-up. When we arrived at the ER my head and lower jaw were throbbing from the fall. The ER staff gave me an IV for hydration and ran the typical tests (blood pressure, heart rate, etc.), an EKG, and later received a CAT scan. After returning from the CAT Scan I was still a bit shaken but was breathing normal. My left arm ached from the injection (my right arm ached after the first injection in series, so I ignored that aches). After being in the hospital for at least two hours I suddenly blacked out again. My sister was sittin I take Ortho Try Cyclen Lo, daily and a multi-vitamin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CAT Scan, EKG, blood pressure, heart rate None None


Page 929
Days 0
State MD
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Syncope
Symptom Text: Information has been received from a health professional concerning a 23 year old female who on 19-DEC-2006 was vaccinated with a first dose of Gardasil. On 20-FEB-2007, the patient was vaccinated IM, into the right deltoid, with a second 0.5 ml dose of Gardasil (lot #655849/0263U). There was no concomitant medication. On 20-FEB-2007, approximately 2 to 3 minutes after the vaccination, the patient fainted for 30 to 45 seconds. It was reported that the rescue squad was called because the patient developed leg numbness spreading to the shoulders after recovering from the fainting spell. It was reported that the numbness lasted from a few minutes. The patient was transported to the emergency room of a local hospital. At the emergency room, the patient had a second episode of syncope at 12:20 p.m. At the time of the report the patient was in the emergency room and had not recovered from the second event of syncope. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 930
Vaers Id: 272911-1 Age Gender F 1.1 VAX Detail: Type MNQ DTAP HPV4 Seriousness: MedDRA PT
Days 0
Received Date 22-Feb-2007 Lot U1948AA AC14B008AA 1447F
State NY
Manufacturer AVENTIS PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS No adverse effect, Wrong drug administered
Symptom Text: none-realized Dtap was given instead of Tdap Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 931
Days 0
State FL
Prev Doses 0
Site Unknown
PERMANENT DISABILITY, SERIOUS Insomnia, Medical device complication, Musculoskeletal pain, Pain, Physiotherapy
Symptom Text: Information has been received from a physician and an office manager concerning a 17 year old female with asthma who on 22-DEC-2006 was vaccinated IM, into the left arm, with a 0.5 ml first dose of Gardasil (lot#654540/0800P). It was reported that at the end of the administration the "safety spring plunger snapped back and caused the patient pain." The office manager explained that this incident was due to human error, the physician was unfamiliar with safety mechanism. On 22-DEC-2006, the patient experienced left shoulder pain and difficulty sleeping on her left arm. On approximately 12-FEB-2007, the patient saw an orthopedic surgeon. The patient underwent an X-ray which revealed no bony abnormality. The orthopedic surgeon recommended that the patient go to physical therapy. At the time of the report, the patient had not recovered. The physician considered the left shoulder pain and difficulty sleeping on her left arm to be disabling events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma X-ray 02/12?/07 - No bony abnormalities


Page 932
Days 1
State KS
Prev Doses 0
ER VISIT, NOT SERIOUS Pain in extremity, Pruritus, Urticaria
Symptom Text: Information has been received from a certified registered nurse anesthetist concerning her daughter, a 16 year old female on contraceptive therapy, who on 08FEB-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM in the left arm. Concomitant therapy included Yasmin for birth control. On approximately 09FEB-2007 (within 24 hours), the patient experienced a sore arm and itching. By 11-FEB-2007 the patient developed "huge hives crawling up both arms and hives to the jaw down around the face." Treatment included Benadryl, 50mg. The patient's mother called the hospital triage nurse, "but child was not hospitalized." A second dose of Benadryl, 25 mg was administered on the evening of 11-FEB-2007. The patient was reported to be recovering. The reporter considered the hives, sore arm and itching to be an other important medical event. Additional information has been requested. Yasmin Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Contraception


Page 933
Onset Date Unknown
Days
State PA
Prev Doses 0
Site Unknown
HOSPITALIZED, LIFE THREATENING, SERIOUS Immune system disorder
Symptom Text: Information has been received from a nurse concerning her niece (age not reported) who on an unspecified date was vaccinated with Gardasil injection. Concomitant therapy was unspecified. Subsequently, the patient experienced "immune system shut down" after receiving the vaccination. The patient had sought medical attention. On an unspecified date, the patient was hospitalized and at the time of reporting it was unknown how long the patient was hospitalized or if she was still in the hospital. It was unspecified if the patient had recovered. The nurse felt that the "immune system shut down" was considered to be immediately life-threatening. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 934
Days 1
State MD
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Fatigue, Nausea, Pain in extremity
Symptom Text: 2-22-07 pt reported feeling dizzy and tired, nauseous, and arm just stopped hurting yesterday, symptoms started day after injection, no lump, no bump at site Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Yasmin NONE NONE cold


Page 935
Days 0
State VA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Headache, Muscular weakness, Nausea, Paraesthesia, Photophobia
Symptom Text: Approx. 2 hours after receiving HPV vaccine pt. developed tingling in left arm (vaccine given in left arm) and then in left leg. At times both extremities felt slight "weak". Pt developed severe right sided headache with nausea and photophobia Mircette-28 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE mild viral URI


Page 936
Days 1
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Body temperature increased, Nausea, Syncope, Vomiting
Symptom Text: Patient received Gardasil vaccine in P.M. during night, nausea, vomited x 1, then fainted. Temperature 100.7 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 937
Onset Date Unknown
Days
State VA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Pregnancy test positive
Symptom Text: Patient has positive pregnancy test on 2-22-07. Cancel all future doses. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Prenatal vitamin (+) pregnancy


Page 938
Days 2
Received Date 26-Feb-2007 Lot ?
State CT
Last Edit Date 27-Feb-2007 Other Vaccine HPV4
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Erythema, Herpes zoster, Pain, Paraesthesia, Pruritus, Rash
Symptom Text: ON 2/22/07 PATIENT STARTED WITH TINGLY,ITCHY AREA ON BACK THAT BECAME A RAISED ,RED RASH ON BACK. IT IS MOSTLY ON ONE SIDE MORE THAN THE OTHER AND IS VERY PAINFUL AND CAUSES HER LEFT SIDE TO BE TINGLY. SHE WENT TO THE WALK-IN BECAUSE IT WAS THE WEEKEND AND THEY DIAGNOSED HER WITH SHINGLES. SHE WAS STARTED ON A COURSE OF VALTREX TO TAKE TID FOR ONE WEEK. SHE IS FOLLOWING UP WITH HER PRIMARY CAE M.D. WHO IS POSSIBLY TO DO LAB WORK. LOOVRAL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE KNOWN NONE KNOWN


Page 939
Days 2
State CT
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Herpes zoster, No adverse effect, Paraesthesia, Rash
Symptom Text: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 16 year old female patient with a possible allergy to AUGMENTIN who on 20-FEB-2007 was vaccinated with her second dose of Gardasil. She was seen at Urgent care on 22-FEB-2007, with a raised red tingling rash on her back, and side. The diagnosis was shingled. Patient was treated with VALTREX TID for a week. She had no adverse symptoms after the first dose of Gardasil. The patient was reported as not recovered at the time of this report. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 940
Days 0
State TN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Convulsion, Fall, Loss of consciousness
Symptom Text: Information has been received from a physician and a nurse in the physician's office concerning a 14 year old female who on 12-FEB-2007 was vaccinated with the first 0.5ml dose of Gardasil. within two minutes of receiving the shot, the patient passed out. it was reported that as she was falling to the ground, it was observed that she was having a seizure. The seizure was described as a "drawing of the right arm". The patient did not have full body tremors. The seizure lasted approximately one minute. The patient was sent to the emergency room, however, was reported as being "Fine" when she left the office. The patient was not admitted to the hospital. The nurse did not know of any treatment given in the ER and believed that the patient was just observed and released. The physician reported that the patient was fine after being released from the emergency room. On 12-FEB-2007, the patient has recovered from the events. It was reported that the patient had no history of seizures and the nurse stated that the patient will continue with the Gardasil series. Upon internal reviews, seizure was considered to be an other important medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 941
Vaers Id: 273065-1 Age Gender F 14.0 VAX Detail: Type MNQ HEPA FLU HPV4 Seriousness: MedDRA PT
Days 2
Received Date 26-Feb-2007 Lot U1822AA 1282F 72004 0955F
State ND
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. CHIRON CORPORATION MERCK & CO. INC.
Prev Doses 0 0 0 0
NO CONDITIONS, NOT SERIOUS Cervix disorder, Contusion, Discomfort, Myalgia, Myalgia, Pain
Symptom Text: 2 days after receiving vaccines started having sharp, stabbing pain, and bruising in cervix area. Muscles ache and burn also inner thighs. No fever, no vaginal discharge. Still having discomfort 12 days afterwards. No sexually active. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Depression, low back pain NONE


Page 942
Vaers Id: 273098-1 (S) Age Gender Vaccine Date F Unknown 18.0 VAX Detail: Type HPV4
Onset Date Unknown
Days
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Condition aggravated, Juvenile arthritis
Symptom Text: Information has been received from a hospital physician concerning an 18 year old female with rheumatism who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced juvenile arthritis, which was assumed to be an acute exacerbation of pre existing rheumatism. Beforehand she had been uncomplaining for a long time. She was admitted to the hospital where a joint puncture was carried out. At the time of the report, the symptoms were ongoing. No further information is available. Other business partner numbers included E2007-01082. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Rheumatism Arthrocentesis


Page 943
Vaers Id: 273099-1 (S) Age Gender Vaccine Date F 22-Feb-2007 13.0 VAX Detail: Type TDAP HPV4 HEPA MNQ Seriousness: MedDRA PT
Days 0
Received Date 27-Feb-2007 Lot AC52B007AA 1426F AHAVB141AA U2158AA
State NY
Manufacturer GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS AVENTIS PASTEUR
Prev Doses 0 0 0 0
Right arm Right arm Left arm
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Chest discomfort, Cough, Dyspnoea, Dyspnoea, Hypersensitivity, Tremor, Wheezing
Symptom Text: None Stated 03/05/07-records received from facility: seen in ED for allergic reaction to vaccines. HX of cough, wheezing and SOB few hours prior to ED visit, symptoms began 30 minutes after vaccines. Initially returned to PCP with c/o chest tightness, difficulty breathing, treated with epipen and benadryl and sent to ED. No swelling of mouth, lips or tongue. Allergies to cat (owns a cat). Uses nasonex for nasal congestion. VS P: 141, resp 20 BP 130/91. Treated with solu medol and ranitidine. Tremors, difficulty breathing. PE unremarkable. Lungs clear, no rhonchi, no wheezes. Admitted for IV steroid treatment. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: records received 4/5/07-CBC:66 neutrophils. 24.6 lymphocytes. NONE NONE


Page 944
Onset Date Unknown
Days
State TX
Prev Doses 0
Symptom Text: Rash on shoulders, chest and back Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 945
Days 43
State IN
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Blister, Herpes virus infection, Hordeolum
Symptom Text: 2/2/07 Vesicles near eyebrow, sty in eyelid - found to be possible herpes. Treated with Valtrex. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 946
Days 0
Received Date 27-Feb-2007 Lot 0011U U2168CA
State MN
Prev Doses 0 1
NO CONDITIONS, NOT SERIOUS Dizziness, Rash, Urticaria
Symptom Text: symptoms started 2-20-07 at 7pm. 1st noticed bumps on arms. She now has hives on her abdomen, face, neck and arms. She also felt faint at times. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Metronidazole 100 mg/day


Page 947
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Amnesia, Convulsion, Dyspnoea, Headache, Incoherent, Influenza like illness, Malaise, Nausea
Symptom Text: Information has been received from a licensed practical nurse concerning a 31 year old female with type II diabetes mellitus, sulfa, morphine, DEMEROL and penicillin allergy and a history of gastric bypass (1994), reverse gastric bypass (1996) and mild asthma who on 12-DEC-2006 was vaccinated with her first dose of Gardasil (lot #653978/0955F), 0.5 ml, IM. Concomitant therapy included metformin HCL (GLUCOPHAGE). On 12-DEC-2006 less than one hour after receiving her first dose of Gardasil, the patient developed "Flu-Like" symptoms. The patient stated that she had a headache and nausea but was not sure if she had a fever. About ten hours after the initial vaccine was administered the patient had a convulsive seizure. The seizure lasted about 2 minutes. The patient was not coherent and was breathing heavy. After the seizure, the patient continued to fell ill and had no memory of the seizure. The patient did not go to the hospital. The patient's husband was an EMT, so he attended to her but did not given her any medication. The patient had no prior history of seizures. The next day the patient felt better. Upon internal review, convulsive seizure was considered to be an other important medical event. Additional information has been requested. GLUCOPHAGE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Gastric bypass, gastric stapling reversal, asthma Type II diabetes mellitus, Sulfonamide allergy, Drug hypersensitivity, Penicillin allergy


Page 948
Days 0
Status Date 01-Mar-2007 Site Left arm
State MA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Dizziness, Hyperhidrosis, Oxygen supplementation, Pallor, Paraesthesia
Symptom Text: Pt was leaving office c/o being dizzy, extreme pallor, perspiring, tingling both hands, 118-70, P116, O2 Sat 98%, O2 given, kept 45 min color improved. Tingling of fingers subsided. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 949
Related reports: 273206-2 Vaccine Date Onset Date 22-Jan-2007 29-Jan-2007
Days 7
Received Date 28-Feb-2007 Lot 0688F U2177AA
State UT
Prev Doses 1
ER VISIT, NOT SERIOUS Aphthous stomatitis, Asthenia, Blepharospasm, Dysaesthesia, Fatigue, Fatigue, Headache, Hypoaesthesia, Hypoaesthesia, Hypoaesthesia facial, Mouth ulceration, Muscular weakness, Myalgia, Pain
Symptom Text: Patient had myalgias at day 7 post vaccine. Severe headache global x <24 hours. Severe muscle weakness. Severe fatigue, symptoms routine except headache which disappeared in 24 hours. 03/07/8/07-records received from rheumatology consultation for DOS 03/02/07-Impression: Myalgias, dysethesias hands and feet, increased fatigability, oral ulceration/cankers;possible rare reaction to either flu or Gardasil. Rule out vasculitis, lupus and other connective tissue disease. C/O severe body pain, weakness, headache lasted 1 day but has had persistent generalized muscle pain. Transient numbness in hand, face and feet. Eyes feel sore, some twitching of eyelids. PMH: Seizure as infant after pertussis vaccine and never completed the series. No recurrence of seizure and did not appear to be febrile seizure. Mother has multiple sclerosis. PE:Muscles tender to palpation pretty uniform throughout body, not so much in hands as in forearms, arms, trunks, legs, calves. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: seizure~Vaccine not specified~1~0~In Patient|aeizure~Vaccine not specified~1~0~In Sibling Severe reaction Gardasil and Influenza vaccine given. Labs:WNL. Rheumatoid factor negative. CK 64 repeat CK 65. Pertussis vaccine. 3/7/07 records received Seizure as infant after pertussis vaccine and never completed the series. Mononucleosis at age 16. Migraines.


Page 950
Days 0
State UT
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Arthralgia, Erythema, Fatigue, Headache, Rash, Rash macular
Symptom Text: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of a seizure response to pertussis vaccine as an infant, who on 11-OCT-2006 was vaccinated with the first dose of Gardasil and on 22-JAN-2007 was vaccinated with the second dose of Gardasil. The mother reported that her daughter "had no adverse experiences" with that vaccination. Concomitant suspect therapy included influenza virus vaccine (unspecified), also administered on 22-JAN-2007. On 29-JAN-2007 the mother stated that her daughter experienced "severe systemic arthritic response," and further explained, "she woke up with severe joint pain, severe fatigue, headaches and a red, blotchy facial rash." The mother reported that her daughter had "multiple lab work" performed, however specific tests or results were not provided. At the time of this report, the patient had not recovered. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Convulsion Allergy to vaccine


Page 951
Days 0
State PA
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Erythema, Pruritus
Symptom Text: 2-27-07 Patient stated "I had redness in my right arm that went down to right hand and knuckles, then it started in left arm and hand it was very itchy. Started 30-45 min after injection given. Yaz birth control Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKDA; no birth defects; no medical conditions NONE reported


Page 952
Vaers Id: 273209-1 Age Gender F 14.0 VAX Detail: Type TDAP MNQ HPV4 Seriousness: MedDRA PT
Days 4
Received Date 28-Feb-2007 Lot C2689AA U1968AA 01874
State SC
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Sensation of heaviness, Skin burning sensation
Symptom Text: Legs burning and hurt next a.m. Tuesday, arms heavy was better on Wednesday, still with something that was gone on Thursday, burning feeling was gone on Wednesday p.m. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 953
Days 0
Received Date 01-Mar-2007 Lot 36970
State FR
Mfr Report Id WAES0702POL00004 Route Intramuscular
Prev Doses
Site Unknown
LIFE THREATENING, SERIOUS Apnoea, Asthenia, Blood pressure decreased, Disorientation, Fall, Head injury, Headache, Hypotension, Retrograde amnesia, Syncope
Symptom Text: Information has been received from a physician concerning a 19 year old female who on 17-FEB-2007 was placed on therapy with human papillomavirus vaccine, 0.5 ml, 0.5 ml prophylaxis. On 17-FEB-2007 the human papillomavirus was administered intramuscular in deltoid muscle according to manufacturer's recommendation. The reporter felt that the injection was made properly. Immediately after taking human papillomavirus vaccine the patient experienced weakness. At that moment the blood pressure was 100/70, total heartbeat count was 76/min, temperature was 97.6 deg F. Dyspnoe and changes on the skin were not observed. The patient was laid down in horizontal position with her legs elevated for 5 minutes. After 4 minutes the regression of symptoms was observed. Approximately after 20 minutes the patient fell down. The syncope was observed. Head injury and apnoe were observed. Restoring of respiratory patency by deviation of head and removing of collapsed tongue was performed. Regression of apnoe was observed. The patient experienced disorientation and retrograde amnesia. The patient remembered only the weakness before syncope, but she did not remember what happened later. Then the patient regained consciousness. After that the headache was observed in the injured place and later in whole head. At that moment the blood pressure was 100/60. total heartbeat count was 79/min, temperature was 97.6 deg F, Meningeal signs were negative. After 2 hours no abnormalities were observed. Subsequently, the patient recovered from syncope, hypotension, weakness, apnoe, disorientation, retrograde amnesia, head injury and headache. The reporter felt that syncope, hypotension, weakness, apnoe, disorientation, retrograde amnesia, head injury and headache were related to therapy with Gardasil. Syncope and apnoe were considered by the doctor to be immediately life-threatening. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure 17Feb07 100/70 mmHg Comment: low, blood pressure 17Feb07 100/60 mmHg, total heartbeat count 17Feb07 76/min, total heartbeat count 17Feb07 79/min, temperature measurement 17Feb07 97.6 deg F UNK


Page 954
Days 1
Received Date 01-Mar-2007 Lot U2136AA 1426F
State NY
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Abdominal pain, Pain, Pyrexia, Rhinorrhoea, Vomiting
Symptom Text: FEELING ACHY AND FEVER (101.0) 48HRS AFTER ADMINISTRATION ALONG WITH VOMITTING X6 THAT NIGHT AND TWICE THE FOLLOWING MORNING. MILD RUNNY NOSE, NO COUGHING, NO WHEEZING, NO HIVES,NO DIARRHEA, MILD ABDOMINAL CRAMPING. NO LETHARGY, NO BEHAVIORAL CHANGES, NO JOINT PAIN OR MUSCLE WEAKNESS. ADMINISTERED IBUPRIFEN 400 MG PO AT 11AM ON 03-01-07. ADVISED SYMPTOMATIC CARE AND SEEK EMERGENCY SERVICE IF SYMPTOMS PERSIST OR WORSEN. SINGULAIR 5 MG QHS AND ALBUTEROL MDI 2 INHALATIONS PRN AMD ASMANEX INHALER 1 INHALATION A DAY Other Meds: TEMP= 101.0 Lab Data: History: Prex Illness: Prex Vax Illns: BRONCHIAL ASTHMA; NO ALLERGIES NONE


Page 955
Days 4
State NY
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Blister, Erythema, Rash, Skin warm
Symptom Text: 4 days after receiving Gardasil vaccine 1st injection patient c/o red, hot rash on both hands and upper thighs, rash on thighs with small blisters lasted approx 1 hour then subsided this went on daily for the next 10 days each time lasting 1 hour. Combivent inhaler, Advantage inhaler, Spiriva inhaler. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Asthma, Emphysema NONE


Page 956
Days 0
State TX
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Convulsion, Fall, Head injury, Injury, Syncope
Symptom Text: Pt received Gardasil and within a minute, pt fainted while sitting on table, fell of and hit her head on a drawer handle, pt began to seize. Called 911, she was stabilized by EMS. 03/05/07-records received from PCP:Five minutes after administration of vaccine episode of eyes rolling back, fell off exam table and struck neck and head on cabinet drawers. Unresponsive to voice with stiffening of all extremities. Event lasted 30 seconds, afterwards alert oriented and recalled speaking to urse prior to event. Glucose 76, O2 sats 99% on RA. BP after episode 99/52, pulse 49. Transported to ER. 03/09/07-records received from facility for DOS 2/16/07-DX:Syncope. Post syncopal seizure. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK labs received 3/9/07.CT head:normal C Spine unremarkable


Page 957
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Malaise, Pallor, Somnolence, Syncope
Symptom Text: Information has been received from physician concerning a 16 year old female patient who on approximately 05-JAN-2007 ("7 weeks ago") was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. The physician reported that the patient stated she "did not feel well when checking out and turned white and fainted when being taken back into the examining room." The physician clarified that the patient "did not lose consciousness or hit her head because he caught the patient." He confirmed the patient fainted "within 5 minutes" of the vaccination, and remained "groggy for up to 30 minutes" after the vaccination. The patient was then "considered recovered," and left the office. The physician considered the events to be disabling. Additional information has been requested. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 958
Days 0
State CA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Bradycardia, Chills, Pyrexia, Vomiting
Symptom Text: Fever, chills, bradycardia, vomiting. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKA


Page 959
Days 0
State FR
Prev Doses
Site Unknown
HOSPITALIZED, LIFE THREATENING, SERIOUS Anaphylactic reaction, Anxiety, Dyspnoea
Symptom Text: Information has been received from a health authority concerning a 16 year old female who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (lot #654740/0859F, batch #NE25270), IM into the left deltoid muscle. It was reported that previous vaccinations were well tolerated. On 01-FEB-2007 at 6:15 pm, the patient experienced anaphylactic reaction with dyspnoea and anxiety reaction and the patient was hospitalized. Subsequently after 75 minutes, the patient recovered from anaphylactic reaction. Anaphylactic reaction was considered to be immediately life-threatening. Case is closed. Other business partner numbers include E2007-01238. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 960
Days 0
State MA
Prev Doses 0
Symptom Text: Mom states patient was fine right after shot #1, but felt faint, looked pale on way out of office - came back to exam room and laid down x 20 minutes then was fine. Mom reports this today when returning for shot #2. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 961
Vaers Id: 273415-1 Age Gender F 16.0 VAX Detail: Type HPV4 DTP FLU Seriousness: MedDRA PT
Onset Date Unknown
Days
Received Date 05-Mar-2007 Lot 0955F C2609AA U2255AAA
State CO
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR AVENTIS PASTEUR
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Injection site pain, Injection site reaction, Pigmentation disorder Left Arm 32mm x
Symptom Text: Received first vaccine on 11/08/2006 never reported it until 03/01/. Area where she got Gardasil injection and tender and Hypo-pigmented. 24 mm 11/08/2006 Right Arm 22 x 25 mm 01/08/2007 Yaz, Celexa Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 962
Vaers Id: 273426-1 (S) Age Gender Vaccine Date F 12-Feb-2007 20.0 VAX Detail: Type VARCEL HPV4
Onset Date 04-Mar-2007
Days 20
Received Date 05-Mar-2007 Lot 1111R 0961F
State PA
Prev Doses 1 0
HOSPITALIZED, LIFE THREATENING, SERIOUS Arrhythmia, Cardiac disorder, Cough, Nasopharyngitis, Oxygen supplementation, Respiratory arrest, Somnolence, Viral myocarditis, Vomiting
Symptom Text: Vaccine administration date 2/12/2007, varicella dose #2 and Gardisil dose #1 administered concurrently. No symptoms until March 4th when in AM noted by mother to have a cold/URI symptoms with cough. Emesis at 11 after soup at 10, napping when mom at home at 3 PM but difficult to arouse. Called 911 and started rescue breathing. Paramedics initially called in stable VS's but required active CPR on gurney by time came into ED. In disorganized vfib in ERresusc'd with PALS then consulted cardiology for ECMO. Cannulated for VA ECMO - on full flow support after 1.5 hours. Heart completely akinetic. Went to cath lab to get biopsies, CAD's and assessment of integrity of heart with very poor tone/strength to heart muscle noted; presumed acute viral myocarditis. Has gotten IVIG. Can't assess neurologic function due to significant drug load. Remains with very disorganized rhythym today; to consider EPS study; also studying family for possible inherited rhythym disturbances. 03/20/07-partial records received from facility, patient remains in hospital. Received ECMO support for cardiac arrest secondary to myocarditis. Endomyocardial biopsy: acute lymphocytic myocarditis with scattered eosinophils. 04/25/07-DC Summary received for DOS 03/04-03/23/07-DC DX: Cardiac arrhythmia. Myocarditis. None Other Meds: Echocardiogram:dilated right ventricle. severely decreased biventricular systolic function. mild tricuspid/mitral insufficiency. atrial septum bulges. small pleural Lab Data: effusion right. None History: Prex Illness: Prex Vax Illns: None


Page 963
Vaccine Date 01-Mar-2007
Days 1
Received Date 05-Mar-2007 Lot C2340AA 1208F U1860AA
State MI
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Chills, Headache, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Nausea, Pyrexia
Symptom Text: Patient awakened early 3/2/07 with fever, chills, nausea and headache. L arm at injection site was tender and puffy. Temperatures ranged from 100.8 to 102.0 throughout the day. 3/3/07-c/o nausea, headache and temp of 100.0 3/4/07- c/o headache and stiff neck. 3/5/07-c/o headache NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none NONE


Page 964
Days 4
State MO
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Burning sensation, Musculoskeletal pain, Pain
Symptom Text: The 2nd injection in November nearly caused my daughter to pass out. She had to lie down & drink some water. The third injection on Feb. 26 was the most painful, with a burning sensation flowing down her arm toward her hand. Approximately 5 days after the injection, she began experiencing very sharp pain in the shoulder she received the injection in. Continues to be in moderate pain, especially with movement of shoulder. birth control pill Other Meds: No medical treatment sought at this time. If doesn't resolve, will seek attention. Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 965
Days 0
State CA
Prev Doses 0
Symptom Text: Patient fainted. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 966
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Grand mal convulsion
Symptom Text: Information has been received from a physician, via a company representative, concerning a 16 year old female patient who in January 2007 ("last month"), was vaccinated with the first dose, 0.5ml, of Gardasil. The physician reported that in January 2007 ("last month"), the patient experienced a grand mal seizure after receiving her first dose. In addition, the physician reported that the "patient has no history of seizures and was taken to the ER. The physician did not know if the patient was admitted. It was unknown if the patient recovered. Upon internal review, grand mal seizure was determined to be an other medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 967
Days 1
State IL
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Injection site mass, Injection site pain, Myalgia, Neuralgia
Symptom Text: pain of muscle/nerve, neck, arm, and upper back. Very tender arm at injection site and knot at injection site. Put on Prednisone and Mobic by doctor after exam of site and pain. BCP (YAZ) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 968
Days 11
State MD
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Amenorrhoea
Symptom Text: Patient states she missed her menses the month after administration of her first Gardasil injection. Another nurse says she heard another patient say the same thing happened to her, but she couldn't remember the second patient's name in order to fill another report. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 969
Vaers Id: 273503-1 Age Gender F 16.0 VAX Detail: Type HPV4 HEP HEPA Seriousness: MedDRA PT
Days 0
Received Date 06-Mar-2007
State OR
Manufacturer MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS
Lot Prev Doses 1208F 0 AHAVB113AA 1 AHBVB261AA 2
ER VISIT, NOT SERIOUS Dyspnoea, Throat tightness
Symptom Text: Ct c/o feeling of throat tightening up and difficulty breathing approx 3 1/2-4 hrs of receiving vaccinations. Went to bed and next am awake with throat tightness and breathing trouble, but left eye was swollen shut, right eye puffy, hands and arms swollen bilat., temp 100.9, earlobes also swollen, rash with red blotchness right hand. No local reaction, no arthralgia, ct saw pcp on 2/27/07. Treated with Benadryl 50mg a 6 hour x 2-3 days. Improved substantially by 3/27 Stratera, Yazmine, 25 mg diphenhydramine QHS prn Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ABN CBC-WBC; Monocytes 12.8%; Lymphocytes 50.7; granulocytes 365; other values WNL NONE poss. slight CAD hives, swelling~~~10~In Sibling


Page 970
Days 0
State MA
Prev Doses 1
Symptom Text: Aftershot, patient developed pain on the side of the body (left) that shot was administered, over left arm, left trunk, and left leg. There was no local redness, swelling, or pain at site of vaccine itself. The patient was treated with Motrin and ice and resolved after 24 hours. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: allergic to strawberries NONE


Page 971
Vaers Id: 273513-1 (S) Related reports: 273513-2 Age Gender Vaccine Date Onset Date F 14-Dec-2006 14-Dec-2006 17.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Back pain, Neck pain, Pain in extremity, Pain in jaw
Symptom Text: Information has been received from a physician concerning a 17 year old female patient with a history of rash after taking amoxicillin, who on 14-DEC-2006 was vaccinated with the first dose, 0.5 ml, in the right arm, of Gardasil. Concomitant therapy included (ORTHO TRI-CYCLEN). In December 2006 (date not specified), the patient "experienced pain at left angle of jaw, neck pain and mid back pain. "The physician reported that the "mother treated daughter with ibuprofen and within 36 hours symptoms improved. The physician stated "the client did not report this reaction at the time. "On 20-FEB-2007 a second dose , 0.5ml, in the left arm, of Gardasil was administered. On 25-FEB-2007, the patient called the office, "complaining of pain at left angle of jaw, mid back pain, and pain in the right deltoid, upper aspect of the right arm, the opposite arm" of where she received the vaccination. At the time of this report it was unknown if the patient had recovered. The physician considered the events to be significantly disabling. Additional information has been requested. ORTHO TRI-CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Drug rash Penicillin allergy


Page 972
Days 0
State NY
Prev Doses 1
ER VISIT, NOT SERIOUS Back pain, Drug hypersensitivity, Mobility decreased, Pain in extremity, Pain in jaw
Symptom Text: Gardasil given Left upper arm on 2/20/07 experienced pain within 24 hours starting at Left angle of jaw and extending down to mid low back, accompanied by right upper outer arm/deltoid pain with shoulder movement and inability to raise Right arm past 90 degrees home prescribed Ibuprofen seen here 2/26/07 and right arm pain persisted. 1st dose Gardasil 12/14/06 given GYN office, also experienced Left neck/jaw pain down to mid back and Right deltoid pain however 1st dose given in Right arm. ORTHO TRI-CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Hx rash on amoxicillin in past NONE


Page 973
Days 8
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Abnormal behaviour, Hallucination, auditory, Mental disorder
Symptom Text: Information has been received from a health professional concerning an 18 year old female patient with no past medical history who on 06-FEB-2007 was vaccinated with a first dose of Gardasil (dosage not provided). There was no concomitant medication. On 14-FEB-2007 the patient developed bizarre philosophical outlook and claimed to hear the voice of a good entity called "it" which could "redress unbalance in her family." She also described the Gardasil as poison coursing through her body. The patient was seen by the reporter who described her behavior as overtly sexual by throwing herself back in the chair with her legs wide open. The reporter stated it was a major psychiatric breakdown and her parents were unable to cope with her at home. The patient was sectioned to be admitted to the hospital. The patient had not recovered as of 23-FEB-2007. Other business partner numbers included E2007-01291. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 974
Days
State FR
Mfr Report Id WAES0702HUN00008 Route Intramuscular
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Hypoaesthesia
Symptom Text: Information ahs been received from a physician concerning a 38 year old female who was vaccinated with Gardasil. On 08-FEB-2007 about two weeks after vaccination, the patient experienced numbness and was hospitalizes. At the time of vaccination patient had chlamidial infection and had taken Botox (botullinum injection used for cosmetic reasons).The action taken with regards to therapy with Gardasil was none. The patient is recovering and the causality reported by treating physician is "possible". No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Chlamydial infection UNK


Page 975
Days 0
State OH
Prev Doses 0
ER VISIT, NOT SERIOUS Asthenia, Injection site anaesthesia, Injection site pain, Tenderness
Symptom Text: Teen reports today pain at injection site for 1 week, then pain resolved and noticed numbness at site, which then went down to fingers, and involving entire arm. Transient, sometimes causing weakness. Site today tender to touch but location varies during exam. Full ROM NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: sent to ped neurology at clinic possible migraines-not diagnosed yet by neuro. says right arm numbness with migraines NONE


Page 976
Days 1
State MA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Arthralgia, Myalgia, Pharyngolaryngeal pain, Swelling
Symptom Text: Pt developed arthralgia, swelling and myalgia involving hands, fingers, elbow joint, toes and ankle joints in 2x hrs after vaccination. Also pt developed sore throat 4 days after immunization. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Strep culture asthma NONE


Page 977
Days 1
State --
Lot Prev Doses 656049/0187U
Site Unknown
NO CONDITIONS, NOT SERIOUS Arthralgia, Myalgia, Pharyngolaryngeal pain
Symptom Text: Information has been received form a registered nurse concerning a 17 year old female, with no pertinent medical history who on 23, Feb 2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 656049/0187U). On 24, Feb 2007. the patient experienced arthralgia, myalgia and sore throat. Patient outcome was unknown. Additional information has been requested. unknown Other Meds: unknown Lab Data: History: Prex Illness: Prex Vax Illns: none


Page 978
Days 1
State VA
Prev Doses
ER VISIT, NOT SERIOUS Body temperature decreased, Headache, Influenza like illness, Neck pain
Symptom Text: Headaches, low grade temp 100 degrees, neck pain, flu-like symptoms. Patient was treated by her family. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Amoxicillin, PCN NONE


Page 979
Days 7
State NC
Prev Doses 0
Symptom Text: C/0 rash/hives starting on arms, wrists spread to face and legs 7-9 days post injection. Treatment prescribed by primary care MD, ----->, Medrol pack --->, -----> rash/hives disappeared within 24 hours of start of treatment. (Loestrin 24) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE - NKDA, NKA NONE


Page 980
Vaers Id: 273565-1 (S) Age Gender Vaccine Date F 07-Mar-2007 20.0 VAX Detail: Type HPV4
Days 0
State IN
Prev Doses 0
ER VISIT, LIFE THREATENING, SERIOUS Chest discomfort, Urticaria, Urticaria
Symptom Text: Within 1 hour of receiving vaccination she developed diffuse urticaria. responded to injected benadryl and depomedrol. 03/09/07-records received. for DOS 3/7/07-developed whole body hives and itching, chest felt heavy. Current medication Ketek. PE: WNL except for confluent hives on arms demulen, ketek, aquatab Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none allergy Tetracycline record received 3/9/07-prior HX tetracycline allergy. dry skin


Page 981
Days 0
State OR
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Headache, Pruritus, Urticaria
Symptom Text: 15 minutes after vaccine - had generalized "itching" feeling every where. She rubbed, hives bright red presented. Took liquid 50 mg Benadryl 1 hr later, no hives, no itchiness but a bad headache. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Sulfa, noreo, Prednisone NONE


Page 982
Days 0
State OK
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Headache, Urticaria
Symptom Text: Information has been received from a nurse practitioner concerning a 20 year old female who on 26, Feb 2007 was vaccinated IM with a 0.5 mL first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The nurse reported that 15 minutes after she had her first vaccination. she came back to the office with generalized hives all over the body where she touched and scratched. The nurse confirmed that there was no reaction at the injection site and she had no problems breathing. The patient was given diphenhydramine hydrochloride and the reaction was gone, but then she had headaches. The patient was reported to have gone home, recovered, after an hour of observation on 26, Feb 2007. Additional information has been requested. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 983
Days 1
State CT
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Erythema, Pruritus, Rash
Symptom Text: Pt developed rash over torso following day after vaccine administered. Rash worsened over week (red patches, itching). Referred to dermatologist given RX clobetasol Propionate and Zyrtec. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma


Page 984
Related reports: 273631-2 Vaccine Date Onset Date 26-Dec-2006 23-Jan-2007 Manufacturer MERCK & CO. INC.
Days 28
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Balance disorder, Clumsiness, Coordination abnormal, Demyelination, Diplopia, Hemiparesis, Hypoaesthesia, Hypoaesthesia, Hypoaesthesia facial
Symptom Text: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies, who on 26-DEC-2006 was vaccinated with a 0.5 mL dose of Gardasil (Lot not reported). There was no concomitant medication. On 23-Jan-2007 the patient developed numbness of her face which eventually spread to her hands and legs. The patient was treated with prednisone and acyclovir. The numbness partially cleared but she then developed double vision, weakness of her right side, unbalance, decreased coordination and clumsiness of her hands. The patient sought unspecified medical attention. On 23-FEB-2007 the patient had a magnetic resonance imaging (MRI), which revealed demyelination and a spinal tap (results not available yet). The physician stated that the patient was starting to get better but was told the patient's parents stopped the Gardasil vaccine series. The dose of Gardasil vaccine was administered by the patient's primary care physician (PCP). The reporter considered the patient's numbness of her face, hands and legs, double vision, weakness of her right side, imbalance, decreased coordination, clumsiness of her hands and demyelination to be other important medical events. Additional information has been requested. NONE Other Meds: magnetic resonance 02/23/07 - revealed demyelination (other results not available), spinal tap 02/23/07 - (other results not available) Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 985
Vaers Id: 273631-2 (S) Related reports: 273631-1 Age Gender Vaccine Date Onset Date F 20-Dec-2006 18-Jan-2007 Unknown VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 29
State --
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Dysgraphia, Hypoaesthesia facial, Mobility decreased, Paraesthesia
Symptom Text: Information has been received from a Nurse practitioner concerning her daughter who on 20-DEC-2006 was vaccinated with her first dose of Gardasil. 4 weeks later, on 18-JAN-2007 the patient developed numbness and tingling on her face, she could not use her right hand to write and had limited mobility with her right leg. The patient was seeing a neurologist. Her outcome was unknown. The reporter considered that the event to be disabling. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 986
Vaers Id: 273640-1 Age Gender F 19.0 VAX Detail: Type PPV MNQ HPV4 Seriousness: MedDRA PT
Days 0
Received Date 08-Mar-2007 Lot 0889F U1932AB 0011U
State ME
Prev Doses
NO CONDITIONS, NOT SERIOUS Erythema, Nausea, Pain, Pyrexia, Swelling
Symptom Text: Right arm red, swollen, has fever, nausea, body aches, no rash or hives. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKDA-Eczema


Page 987
Days 0
State TX
Mfr Report Id Route Subcutaneously
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Hypokinesia, Injection site pain
Symptom Text: At one month post injection pt was having continued pain at injection site. At two months, not much improvement. Difficulty moving arm. Refused 2nd and 3rd injection because of this reaction. Yasmin, Zyrtec prn Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE seasonal allergies NONE


Page 988
Days 10
Received Date 08-Mar-2007 Lot 1163F U2166MA
Status Date 09-Mar-2007 Site Left arm Left arm
State NY
Prev Doses 0 1
Symptom Text: First seizure 10 days after first gardasil vaccine. Two months later, second seizure episode 16 days after second gardasil. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: seizure~Human Papillomavirus Recombinant Vaccine, Quadrivalent (Gardasil)~2~12~In Patient MRI and EEG. Developmental delay


Page 989
Days 46
State --
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Blood test, Infectious mononucleosis
Symptom Text: Information has been received from the mother of a 18 year old female consumer who in late December 2006, was vaccinated 0.5 mL IM with her first dose of Gardasil. The patient came down with mononucleosis on 15-FEB-2007. Unspecified Blood work was performed. The patient was reported as recovered on 19FEB-2007. No further information is available. Unknown Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 990
Days 0
State --
Prev Doses 1
Site Unknown
HOSPITALIZED, SERIOUS Condition aggravated, Contusion, Idiopathic thrombocytopenic purpura, Infectious mononucleosis, Injection site haematoma, Injection site haematoma, Petechiae
Symptom Text: Information has been received from a physician at health conference, concerning her 15 year old daughter with a history of bleeding gums (attributed to orthodontic braces) previous 7 days, menstruation heavier 7 days earlier, slight sore throat approximately 1 week prior, and infectious mononucleosis showed possible acute infection, but seroconversion did not occur until 05-FEB-2007, possibly delayed by prolonged steroid treatment. On 03-OCT-2006, the patient was vaccinated with first dose of HPV vaccine. No reaction occurred. On 24-NOV-2006, the patient was vaccinated with second dose of HPV vaccine (lot # not reported), one month after the first dose. No reaction occurred. On 12-DEC-2006, poliovirus vaccine boosterix injection was given. A 5cm bruise developed within 4 hours. On 12-DEC-2006, the patient was hospitalized with a platelet count greater than 5. Signs included: 4 cm hematoma at the site of immunization left upper arm, few petechiae on lower abdomen, no hepato-splenomegaly. Provisional diagnosis of immune thrombocytopenia (ITP) was made. The patient was treated with Prednisone 75 mg stat, 3 weeks of 50 mg Prednisone, followed by decreasing dose over the next month. By 29-JAN-2007, the patient's platelet count slowly returned to normal. The physician commented: "This is case of ITP, probably due to infectious mononucleosis, but diagnosed 18 days after the second dose of HPV vaccine (symptoms started approximately 10 days after the vaccine). I am hopeful it was due to Glandular fever but an interesting co-incidence and an unusual presentation of "IW." Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Gingival bleeding; Heavy periods; Sore throat; Steroid therapy; infectious mononucleosis platelet count 12/12/06 >5 150-400, platelet count 01/29/07 150-400 normal


Page 991
Related reports: 273722-2 Vaccine Date Onset Date 29-Jan-2007 Unknown Manufacturer MERCK & CO. INC.
Days
State AZ
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Fatigue, Hypotrichosis, Loss of consciousness, Malaise, Night sweats
Symptom Text: 1 hour after injection, pt passed out in class x 15 seconds. Felt "sick and exhausted" rest of the day. Coordination was off. Has experienced night sweats since injection and feels hair is thinning. Tricycline Lo Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 992
Days 0
State NJ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthenia, Circulatory collapse, Dizziness, Nausea
Symptom Text: Information has been received from a physician concerning his 22 year old female cousin with no known drug allergies, who on 29 Jan 2007 was vaccinated IM into the arm with a first dose of Gardasil. There was no concomitant medication. On 29 2007, the patient became dizzy, nauseous and collapsed about 1 hour after vaccination. The patient recovered rapidly and went home to bed. It was noted that the patient's weakness continued for 24 hours. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 31 Jan 2007 the patient recovered. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 993
Days 0
Received Date 09-Mar-2007 Lot 1062F 1427F AHAVB143BK
State CO
Type VARCEL HPV4 HEPA
Manufacturer MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS
Prev Doses 1 0 0
NO CONDITIONS, NOT SERIOUS Erythema, Injection site vesicles, Oedema peripheral, Pain in extremity, Skin warm
Symptom Text: Right upper arm red, hot, swollen 18 cm x 18 cm the circumference of arm. 5 small fluid filled vesicles around injection site. Patient c/o pain in effected arm. No systemic s/s. Doctor name reported examined patient and recommended Advil for pain ice to effected area. Advised to go to E.R. if symptoms worsened or systemic involvement occurs and contact PCP. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 994
Days 0
Received Date 09-Mar-2007 Lot 1249F 0012U
State ID
Type VARCEL HPV4
Prev Doses 0 0
ER VISIT, NOT SERIOUS Pruritus generalised, Rash maculo-papular
Symptom Text: Patient started intching, mostly on trunk, last night; woke up itching all over and has rash (fine maculopapular rash) all over; given hydroxyzine for itching; Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Orthocyclen N/A Allergy to sulfa None


Page 995
Vaers Id: 273751-1 Age Gender M 0.3 VAX Detail:
Days 1
Received Date 09-Mar-2007 Lot NA NA
Status Date 12-Mar-2007 Site Right leg Right leg
State NC
Type HPV4 DTAPH
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Pyrexia, Rash macular, Vomiting, Wrong drug administered
Symptom Text: Wrong Vaccination was give. My son was given the HPV vaccine which is for women 18-26 years old. So far just normal post vaccine responses. Some blotching of skin, fever, and vomiting. Pediatric office contacted me on March 8th to report the wrong vaccination administration Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: n/a


Page 996
Days 0
State CA
Last Edit Date 12-Mar-2007 Other Vaccine MNQ
Prev Doses 0
ER VISIT, NOT SERIOUS Abdominal pain, Dizziness, Nausea
Symptom Text: Patient complained of abdominal pain about 3 hours after receiving vaccines then the next day had nausea and dizziness. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 997
Days 1
Received Date 12-Mar-2007 Lot U1968AA 00130
State MI
Prev Doses 0 0
ER VISIT, NOT SERIOUS Body temperature increased, Chills
Symptom Text: Elevated temp and chills approx. 16 hours after vaccine given Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None Prevacid 30mg Q day / Allegra


Page 998
Days 1
State MI
Mfr Report Id M12007004 Route Unknown
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthenia, Confusional state, Dehydration, Diplopia, Headache, Hypersomnia, Hypoaesthesia, Hypokinesia, Musculoskeletal pain, Nasal congestion, Orthostatic hypotension, Pain in extremity, Paraesthesia, Pharyngolaryngeal pain, Sensory disturbance, Stress, Vision blurred
Symptom Text: 1/31/07 tc from mother-states patient had HPV vaccine 1/19/07 on 1/20/07 c/o achy arms. Developed headache that comes and goes and blurred vision the comes and goes. On 1/26/07 c/o weakness-couldn't move-went to hosp ER-was in ER for 8 hours. No convulsion for use of symptoms. Able to move now but has charge of sensation of left side. Mom states had been sleeping a lot. 2/21/07-Return call from mom. Completed form with available info, lasted 6 daysnumbness/tingling. 03/30/07-records received from reporter. PE:WNL Pain when walking able to walk with some poor effort on examination but grossly normal musculoskeletal exam. Dehydration, musculoskeletal pain. Orthostatic blood pressure mostly likely due to poor oral intake. Sore throat and nasal congestion. Numbness in toes and feel and intermittent blurring of vision and seemed confused. Tired. Mother concerned about possible bipolar disorder. Multiple stressors in home life. Recommended mental health care provider Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: all tests came back normal records received 3/30/07-EKG normal. CXR normal. NONE NONE


Page 999
Days 0
State WI
Lot Prev Doses 0637F 0 AHAVB129AA 0
NO CONDITIONS, NOT SERIOUS Incorrect dose administered
Symptom Text: Adult dose of Hepatitis A given (1440 elu) instead of pediatric dose of Hepatitis A (720 elu) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Adderall XR 20 mg daily ADD, Tetracycline 500 mg BID acne NONE left elbow cracking ADD, Right ankle sprain, Acne


Page 1000
Days 0
State VA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Burning sensation, Erythema, Pruritus
Symptom Text: Within 1/2 hr of receiving injection pt complained of face itching. Within 1 hour face and neck burning red and itchy. Given Benadryl at school. Slept several hours, still complaining of itching when she woke up. Resolved without further treatment. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Psoriasis NONE


Page 1001
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Abortion, Abortion spontaneous, Drug exposure during pregnancy
Symptom Text: Information has been received from a registered nurse through a pregnancy registry concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. The patient was pregnant, and on 28-FEB-2007 the patient had a miscarriage or abortion after receiving the first dose of Gardasil. The patient sought unspecified medical attention. At the time of this report, the nurse was unsure if the patient had a miscarriage or abortion. Upon internal review, the patient's miscarriage or abortion was considered an other important medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = unknown). UNK


Page 1002
Days 14
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Fatigue, Headache
Symptom Text: Information has been received from a physician concerning a 25 year old female who on 02-JAN-2007 was vaccinated with the first dose of Gardasil (lot # not reported), IM in the left arm. Concomitant medication was not reported. On approximately 16-JAN-2007, two to three weeks post vaccination, the patient experienced extreme fatigue. On approximately 06-FEB-2007, five weeks post vaccination, the patient experienced cephalgia. The patient was hospitalized for check-up, but no diagnosis could be established. The patients extreme fatigue and cephalgia persisted. Other business partner numbers included E200701394. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1003
Days 1
State FL
Prev Doses 0
Symptom Text: Patient had Gardasil (1st injection of series) on 2/26/07 10:00 am, 24 hours later developed pink rash on arms. torso and neck. Patient complain of itching, denies using any new meds or products. Patient came in for OV with doctor, was given Medrol dose pack. Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1004
Days 2
State PA
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site swelling
Symptom Text: Approximately 10 cm local reaction of redness and swelling Left arm. Treatment: warm soaks. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Enuresis NONE Imipramine


Page 1005
Days 0
State VA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Abortion induced, Drug exposure during pregnancy
Symptom Text: Information has been received from a licensed practical nurse, for the Pregnancy Registry for Gardasil concerning a 25 year old female with drug hypersensitivity to ENTEX, erythromycin, codeine, LORTAB, and IMITREX and a history of pregnancy who on 21-NOV-2006 was vaccinated with first dose of Gardasil (lot # 654702/0011U) IM. On 22-JAN-2007, the patient was vaccinated with second dose of Gardasil (lot # 654702/0011U), IM. Concomitant therapy included amitriptylline hydrochloride. The patient sought medical attention. On an unspecified date, urine beta-human chorionic gonadotropin test was positive for pregnancy. The patient's last menstrual period was December 2006 (gestation: first trimester), expected date of delivery is approximately September 2007. No other information was available at the time of reporting. Additional information was received from a health professional from the physician's office via telephone. It was reported that the patient terminated her pregnancy (date not reported), not because of Gardasil but for other reasons. The outcome of the induced abortion was not reported. Upon internal review, abortion induced was determined to be an Other Important Medical Event. No additional information is expected. amitriptyline hydrochloride Other Meds: urine beta-human - positive for pregnancy Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy Pregnancy NOS (LMP = Unknown) Drug hypersensitivity


Page 1006
Days 39
State IL
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Eosinophil count increased, Headache, Neck pain
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female who on 03-JAN-2007 was vaccinated with Gardasil (lot # not reported). On 11-FEB-2007, the patient experienced neck pain, and headache. Medical attention was sought. The patient was hospitalized. The patient had an "eosinophil type reaction" also. Laboratory evaluation revealed elevated eosinophils. The outcome of the neck pain, headache, and eosinophil type reaction was snot reported. No further information was available at the time of reporting. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: eosinophil count 02/11/07 - elevated UNK


Page 1007
Days 0
State OH
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Eye infection, Eye swelling, Swelling face
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated IM with the first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 05-MAR-2007, two hours post-vaccination, the patient developed swollen eyes and face and went to an emergency room. The patient underwent sinus films, which were noted to be negative, and was administered BENADRYL and unspecified antibiotics for a possible eye infection. The patient was released that same evening. On 07-MAR-2007, the physician contacted the patient and reported that there was "not much improvement." The patient's swollen eyes and face persisted. Eye and face swelling were reported as other important medical events. Additional information has been requested. hormonal contraceptives Other Meds: nasal sinus X-ray 03/05/07 - negative Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1008
Days 0
State FL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Hyperhidrosis, Pallor, Syncope
Symptom Text: Appeared patient fainted just after vaccine was given, sl diaphoretic pale, recovered quickly after ammonia inhaler was used. Patient rested water was given, left office feeling well. LOESTRIN 24 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1009
Related reports: 273916-2; 273916-3 Vaccine Date Onset Date Days 31-Aug-2006 31-Aug-2006 0 Manufacturer MERCK & CO. INC.
State ND
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Loss of consciousness, Tremor
Symptom Text: Patient walked to lobby after shot and passed out, then body shook. She was helped back to exam room and observed. She hit back of head and no bump forward. Iced area for 30 minutes. She left in 45 minutes in good condition. Ct scan normal next day. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CT- brain - normal NONE NONE


Page 1010
Received Date 16-Mar-2007 Lot UNKNOWN
State ND
Prev Doses 0
ER VISIT, NOT SERIOUS Asthenia, Computerised tomogram, Convulsion, Diplopia, Dizziness, Dizziness, Injection site pain, Loss of consciousness, Musculoskeletal stiffness, Nausea, Syncope, Vision blurred
Symptom Text: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1011
Received Date 16-Mar-2007 Lot UNKNOWN
State ND
Prev Doses 0
ER VISIT, NOT SERIOUS Asthenia, Computerised tomogram, Convulsion, Diplopia, Dizziness, Dizziness, Injection site pain, Loss of consciousness, Musculoskeletal stiffness, Nausea, Syncope, Vision blurred
Symptom Text: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1012
Days 3
State NY
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Arthralgia, Myalgia
Symptom Text: Two days after injection, complained of joint pains, myalgia not relieved with use if Ibuprofen missed 2 days of school. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 1013
Related reports: 273919-1 Vaccine Date Onset Date 23-Feb-2007 01-Mar-2007 Manufacturer MERCK & CO. INC.
Days 6
State NY
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Arthralgia, Myalgia
Symptom Text: Generalized myalgia, arthralgia after 2nd injection (HPV). TX with Motrin 200 mg - 400 mg Q 4 hours x 2 days. Pt missed 2 days of school. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 1014
Days 1
Received Date 14-Mar-2007 Lot P0688F
State WY
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Erythema, Oedema, Oedema peripheral
Symptom Text: 1st Injection with slight erythema and edema. 2nd Injection noted slight edema and erythema, then next am woke with swollen area over most of deltoid area, continue to increase over next 24 hours - arm swollen from elbow to shoulder and continues for 8 days. Resolved completely. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Allergy to Keflex and Motrin NONE


Page 1015
Vaers Id: 273922-1 Age Gender F 12.0 VAX Detail: Type TDAP HPV4 MMRV Seriousness: MedDRA PT
Days 0
Received Date 14-Mar-2007 Lot C2720AA 1424F 1397F
State MI
Mfr Report Id Route Intramuscular Intramuscular Subcutaneously
Prev Doses
ER VISIT, NOT SERIOUS Body temperature increased, Fatigue, Pharyngolaryngeal pain, Pyrexia, Rash
Symptom Text: Six hours s/p injections developed fever, rash up right arm, right side of neck and face. Also developed sore throat in 24 hours. Temp = 102. Rash responded to Benadryl except for local injection sites. Is having RLQ pain but that started before injections. Generally feels fatigued as well. No rash on left arm. ZYRTEC Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Depression, seasonal allergies Vague RLQ abd pain


Page 1016
Days 7
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Oedema peripheral
Symptom Text: Patient c/o arm swelling 7 days after 1st injection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Birth Control NONE NONE NONE


Page 1017
Onset Date Unknown
Days
Received Date 14-Mar-2007 Lot U1974AM 0263U
State NY
Prev Doses
NO CONDITIONS, NOT SERIOUS Erythema, Urticaria
Symptom Text: Hives come days after vaccine, red on arm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1018
Days 0
State SC
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Tinnitus
Symptom Text: "Dizziness, ringing in ears" per patient. Treatment: Patient laid down for 15-20 minutes, sx's resolved. Vital signs were stable before, during and after sx's. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 1019
Related reports: 273930-2 Vaccine Date Onset Date 06-Mar-2007 07-Mar-2007 Manufacturer MERCK & CO. INC.
Days 1
State PA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Body temperature increased, Erythema, Nausea, Oedema peripheral, Vomiting
Symptom Text: Swelling and redness of arm. Swelling approximately 5 cm, erythema > 26cm also nausea, vomiting, increase temp. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1020
Related reports: 273930-1 Vaccine Date Onset Date 06-Mar-2007 06-Mar-2007 Manufacturer MERCK & CO. INC.
Days 0
State PA
Prev Doses 2
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Fluid replacement, Nausea, Pyrexia, Vomiting
Symptom Text: Information has been received from a 24 year old female who on 06, Mar 2007 was vaccinated intramuscularly with a 0.5 mL third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). The patient mentioned that she did not have any problems with dose 1 or 2 and that these doses were were given in the outer part of her arm. She reported that the third dose was given less in the outer area and more towards the inner arm but still in the muscle. On 06, Mar 2007, the patient started to throw up. and she developed a fever. On 09, Mar 2007, the patient went to the emergency room due to continued vomiting and dizziness. She was treated with intravenous fluid and was released at approximately 04:00 pm. As of 12, Mar 2007, the patient continued to experience dizziness and nausea. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: unknown none


Page 1021
Days 1
State NY
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Pyrexia
Symptom Text: Pt stated she had slight fever after 1st shot. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Birth Control NONE NONE NONE


Page 1022
Days 0
State MA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Fatigue, Nausea
Symptom Text: Nausea extreme fatigue also fatigue after #1 Gardasil and Menactra on 1/3/07 (not reported). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1023
Days 2
Received Date 14-Mar-2007 Lot U2159AA NULL U2240AA
State NY
Mfr Report Id 200603463 Route Intramuscular Unknown Intramuscular
Prev Doses 0 0 1
NO CONDITIONS, NOT SERIOUS Erythema, Flushing, Pruritus, Rash macular
Symptom Text: Initial report received from a health care professional on 12 December 2006. A 19 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 23 November 2006, the patient called to report red spots on hands. The patient did not have any illness at the time of vaccination. She was treated with Benadryl. She was not seen at the doctors office and has moved. It was reported that she recovered. Nevacor, Birth control pills, Celexa, Clonitin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1024
Days 0
State CT
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Headache, Pain, Pain in extremity
Symptom Text: C/O pain in extremities and headaches since administration of Gardasil (HPV Vaccine), constant pain, rated 6-7/10 on pain scale. Does not interfere with daily activity. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CBC, ESR, Lyme, WB, ANA, DS DNA pending NONE NONE


Page 1025
Days 13
State SD
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral, Pain, Pruritus, Skin tightness
Symptom Text: erythema, pruritis, edema of palms, soles, fingertips, Pain with flexion of fingers, skin taut & shiny. symptoms started 2/27/07 continued though 3/1/07. Treated with ibuprofen 200 mg two tabs every 4-6 hours and diphenhyrdamine 25 mg at bedtime. Ortho-tryclen Lo Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: allergies to cedar wood products & Demerol none


Page 1026
Days 14
State AL
Prev Doses 0
ER VISIT, NOT SERIOUS Injection site induration, Muscle atrophy
Symptom Text: Area of induration and questionable muscle atrophy appeared 2 weeks after vaccine was administered. Increased to 1 inch diameter over 7-10 day period. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Celebrex Minocycline None None None


Page 1027
Days 0
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Dizziness, Heart rate normal, Hypoaesthesia, Paraesthesia, Rash macular, Tremor
Symptom Text: Approximately 30 secs after vaccine was administered, pt became light headed and dizzy. Nurse had pt lay flat and administered ice pack to back of neck. Pulse normal. Ten minutes later, nurse asked how pt was feeling, she complained of still being dizzy and that both arms felt numb/ tingly. Pulse rechecked, left arm slower than right. Both of patient's arms began to shake. Red blotches noted on patient's chest and neck. The nurse practioner in the office was called and came to eval patient. Nurse practioner ordered Benedryl 25mg to be given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1028
Days 0
State WI
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site pain, Injection site swelling, Skin tightness
Symptom Text: About 2 minutes after vaccine (Gardasil, 2nd dose), patient noticed pain, swelling/tightness of upper arm near vaccine, and streaks of slightly swollen reddened skin out to about 4 cm surrounding injection site. Subsided within 8 minutes. Treatment was MD assessment and Claritin 10mg reditab. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none NONE NONE


Page 1029
Vaers Id: 274068-1 (S) Related reports: 274068-2 Age Gender Vaccine Date Onset Date F 28-Feb-2007 28-Feb-2007 18.0 VAX Detail: Type MEN HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Days 0
Received Date 16-Mar-2007 Lot NULL 0688F
State --
Prev Doses 0
ER VISIT, PERMANENT DISABILITY, SERIOUS Convulsion, Fall, Head injury, Orthostatic intolerance, Syncope, Vomiting
Symptom Text: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a first dose of Gardasil, Lot #653735/0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she fell after fainting. The patient was slow to wake and was Orthostatic (time line was unspecified). The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1030
Vaers Id: 274068-2 (S) Related reports: 274068-1 Age Gender Vaccine Date Onset Date F 28-Feb-2007 28-Feb-2007 18.0 VAX Detail: Type MEN HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Days 0
State --
Prev Doses 0
ER VISIT, PERMANENT DISABILITY, SERIOUS Convulsion, Fall, Head injury, Orthostatic hypotension, Syncope, Vomiting
Symptom Text: Initial report received on 22 March 2007 from an other manufacturer, reference, reference number WAES 0703USA00641. This manufacturer had received the original report from a pharmacist. Verbatim from report: Information has been received from a pharmacist concerning an 18 year old female patient who on 28FEB-2007 was vaccinated with a first dose of Gardasil lot # 653735-0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she fell after fainting. The patient was slow to wake and was orthostatic (time line was unspecified. The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. "Upon internal review, seizure was considered to be an other important medical event." Additional information has been requested." Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: It was unknown if the patient had any pre-existing medical conditions at the time of the vaccinations on 28 February 2007.


Page 1031
Days 10
State WA
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Crying, Pain in extremity
Symptom Text: Information has been received from a medical assistant and a nurse practitioner concerning an 11 year old female with no relevant medical history reported who on 08-FEB-2007 was vaccinated intramuscularly in the right deltoid wit a 0.5 ml dose of Gardasil (lot 654702/0011U). Concomitant therapy included METADATE. On approximately 18-FEB-2007 or 19-FEB-2007, the patient developed upper right arm pain. The patient was seen on 21-FEB-2007 and 02-MAR2007 for the upper arm pain. The pain occurred on the whole outer portion of the upper arm. The patient has no fever. Office notes indicated that "normal flexion of the elbow without problems with bilateral strength. Normal anterior and posterior rotation of shoulder. Normal internal and external rotation of shoulder. Active abduction of only 90 degrees, stopping due to pain. Able to rotate full 180 degrees with passive range but crying due to tears. Diagnosis was arm pain without reduction of strength, secondary to HPV injection. "The patient was treated with ibuprofen 350mg every 6 hours for 4 to 5 days. The nurse practitioner reported that she assumed the patient recovered from the arm pain because the patient did not return for a follow-up visit scheduled on 08-MAR2007. The nurse practitioner considered the patient's upper arm pain an other important medical event as the patient's pain lasted longer that the indicated time frame of 48 hours for this experience. Additional information has been requested. METADATE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1032
Days 0
State IN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Throat tightness, Urticaria
Symptom Text: Information has been received from a physician concerning a female (age not reported) with a history of allergic reaction to antibiotics who on 07-MAR-2007 was vaccinated with first dose of Gardasil (lot # not reported) injection. On 07-MAR-2007, after being vaccinated, the patient broke out in severe hives and her airway began to close. Medical attention was sought. The physician administered an injection of Benadryl. The patient was admitted to the emergency room, it was unknown if the patient was admitted to the hospital. On 08-MAR-2007, the patient recovered. No further information was provided. Upon internal review, airway began to close was considered to be an other important medical event. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic reaction to antibiotics UNK


Page 1033
Days 0
State OH
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dysphonia, Eye swelling, Nasal congestion, Swelling face, Tenderness, Throat irritation
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated by injection with the first dose of Gardasil. It was reported that the patient experienced an adverse experienced 2 hours after receiving Gardasil. The patient went to the emergency room with a swollen face and eyes, no fever reported. The patient received eye drops and BENADRYL. On 06-MAR-2007 the patient returned to the clinic with tender and a "little puppy eyes". On 07-MAR-2007 the patient had an itchy throat and her eyes were still tender. On 08-MAR-2007, the patient sounded "nasal". The pat6ient sought unspecified medical attention. The physician added an antibiotic and the patient was still taking diphenhydramine hydrochloride. The patient has a "respiratory panel". The physician reported that the patient will not continue the series. At the time of the report, it was unknown if the patient recovered. The physician considered swollen face and eyes, tender eyes, itchy throat, and sounded "nasal" to be other important medical events. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory - respiratory panel UNK


Page 1034
Onset Date Unknown
Days
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Arthralgia, Joint swelling, Urticaria
Symptom Text: Information has been received from a dermatologist concerning a female with a sore throat (developed at the time of vaccination) who was vaccinated with primary dose of Gardasil. Concomitant therapy included acetaminophen. Subsequently, four days post vaccination, the patient developed a urticarial rash and joint swelling with arthralgia. The patient was hospitalized for three days, and was treated with erythromycin and CORTISONE. On 07-MAR-2007, the patient contacted the the dermatologist and reported that symptoms had improved notedly. On an unspecified date, the patient had recovered, although, was still receiving CORTISONE therapy. No further information is available. Other business partner number included E2007-01485. acetaminophen Unk - Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1035
Days 0
Received Date 16-Mar-2007 Lot NULL NULL NULL NULL
State FL
Mfr Report Id Route Unknown Unknown Unknown Unknown
Type VARCEL HEPA MNQ HPV4
Manufacturer UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses
ER VISIT, NOT SERIOUS Laceration, Syncope, Tooth repair
Symptom Text: 2-19-07 child had well check up, received vaccines of Gardasil, Hep A, Menactra, Varicella. Approx at 3:00pm had syncopal episode on the way out of the office. First aid rendered for lip laceration. B/P and vital signs checked, reverse trendelenburg position. Sent to dental office for tooth repair. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE PO2 99%


Page 1036
Days 0
State OH
Prev Doses 0
ER VISIT, NOT SERIOUS Anxiety, Confusional state, Dyspnoea, Erythema, Fall, Loss of consciousness, Neck injury, Syncope
Symptom Text: Syncope episode at checkout window 4 min after Gardasil vaccine given. Upon forward fall, pt sustained blow to anterior aspect of neck on our counter top. Unconscious for approx 30-60 sec, then alert but confused as to what happened for about 1 min. Labored breathing and anxiety approx 4-5 min then relaxed. Red raised mark on soft tissue of anterior neck. Remained in supine position with neck neutral at still. EMS here within 10 min. To ER pre EMS with cervical collar and neck immobilizer on. Yaz birth control Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: In emergency room CT head, brain, CT neck soft tissue, BMP, CBC, EKG. Abnormal uterine bleeding, irregular menstruation, Menorrhagia, Pelvic pain.


Page 1037
Days 0
State NY
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Accidental exposure, Incorrect dose administered, Sensory disturbance, Vaccination complication
Symptom Text: Initial and follow up information has been received from a nurse practitioner concerning a 22 year old female student with no acute illness or chronic disease and food allergy to eggplant who on 08 Nov 2006, at 14:00, was vaccinated witha second dose of Gardasil. It was reported that the patient pulled away during adminstration due to "strange sensation" and a significant amount medication went down the patient's arm. It was estimated that only one third to one half of the dose was administered. It was reported that the patient had to repeat the second. On 08 Nov 2006, the patient recovered from the event. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE food allergy


Page 1038
Days 0
State NH
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Cold compress therapy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Symptom Text: Informatio has been received from a physician's assistant concerning a 22 year old female who on 25 Jan 2007 was vaccinated IM with a second 0.5 ml dose of Gardasil. On approximately 25 Jan 2007, the patient experienced a 1.3 inch area of swelling, redness, tenderness and itchiness at the injection site. The patient notified the physician's assistant 5 days after vaccination. It was unknown when the events started. The patient was treated with cool compresses and antihistamines with unknown results. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. It was also reported that on 07 Nov 2006, the patient was vaccinated with a first dose of Gardasil. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1039
Days 5
State MD
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a licensced practical nurse concerning a 25 year old female with no medical history or allergies, who on 26 Jan 2007 was vaccinated a first dose of with Gardasil (yeast) (lot#653736/0014U). Concomitant therapy included hormonal contraceptives (unspecified). On 31 Jan 2007 (also reported as four to five days later), the patient developed hives. The patient went to her primary care physician for treatment of the hives. She was prescribed prednisone and Benadryl. Later that day, she went to the emergency room. On 01 Feb 2007 the patient told the nurse her hives were worse. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 1040
Onset Date Unknown
Days
State UT
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Injection site discolouration
Symptom Text: Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 02 Nov 2006 was vaccinated intramuscularly in the right arm with Gardasil. Concomitant therapy included Yasmin. On 14 Jan 2007 the patient received her second vaccination of Gardasil intramuscularly in the left arm. On approximately 09 Nov 2006 the patient experienced a lighter coloring of the skin at the injection site. It was reported that the patient did not experience any itching or swelling. On approximately 21 Jan 2007 the patient experienced lighter coloring of the skin at the injection site. At the time of this report the patient's skin discoloration in both arms had not resolved. Additional information has been requested. Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 1041
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure normal, Dizziness, Fall, Heart rate normal, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 21 year old female with no known allergies who on 01-FEB-2007 was vaccinated intramuscularly in the right deltoid with Gardasil (lot # not provided). The physician reported that after administering the injection she "turned around literally for a second" and when she turned back to the patient she found her "on the floor, with her rear in the air". The physician stated that she called for her assistant for help and the patient was already conscious, "she was only out for a second". The patient reported to the physician that she felt dizzy and felt like she instantly went to sleep. The physician reported that the patients blood pressure and pulse were normal (actual measurements not provided). The physician reported that the patient was observed in the office, had no additional episodes and considered to have recovered from the event and sent home. The physician stated that she did not feel the event was disabling and would continue the series of vaccination of Gardasil with the patient, but would have her reclined when administering future vaccinations. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1042
Days 0
State NJ
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 26 year old female with a history of syncope when giving blood, who on 11-Jan-2007 was vaccinated with Gardasil (lot #653978/0955F). It was reported that the patient fainted 15 minutes after vaccination. The patient subsequently recovered. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Syncope


Page 1043
Days 0
State WV
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dysgeusia
Symptom Text: Information has been received from a physician concerning a "23 or 24" year old female with no pertinent medical history or drug reactions/allergies, who on approximately 11-Jan-2007 was vaccinated with Gardasil (0.5 ml). The physician reported that 30 seconds following vaccination, the patient experienced an intense metal taste in her mouth, however immediately recovered. No further details were provided. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1044
Days 0
State IN
Prev Doses
ER VISIT, NOT SERIOUS Dizziness, Injection site erythema, Injection site rash, Presyncope
Symptom Text: Information has been received from a physician via a company representative, concerning a 16 year old female who on approximately 02-Dec-2006 was vaccinated IM in the left arm with Gardasil. After receiving the injection, the patient went to school and later during the day, she got very dizzy "that she almost passed out.". She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 1045
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Scleroderma
Symptom Text: Information has been received from an office staff member concerning a 14 year old female relative who, on an unspecified date, was vaccinated with a first dose of Gardasil. A couple of days after vaccination, the patient was diagnosed with scleroderma, an autoimmune disease. The patient was referred to a specialist and was currently being treated. At the time of this report, the patient's scleroderma persisted. No product quality complaint was involved. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1046
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Gait disturbance
Symptom Text: Information has been received from a nurse practitioner, via a company representative, concerning an approximately 22 year old female who was 6 weeks post partum and had completed a pelvic exam followed by the vaccination of the first dose (dose unspecified) of Gardasil. The nurse reported that 45 minutes after the appointment, the patient began to experience dizziness. The sensation of movement/dizziness" made it difficult for the patient to walk and persisted for about four hours, then abruptly resolved with no lingering effects. The patient sought unspecified medical treatment. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1047
Days 24
State TX
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Vaginal swelling
Symptom Text: Information has been received from a physician concerning a 22 year old female with a history of human papilloma virus infection who on 08-DEC-2006 was vaccinated with Gardasil. In January 2007, the patient experienced swelling of her vaginal walls. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Human papilloma virus infection.


Page 1048
Days 0
State IL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Influenza, Insomnia
Symptom Text: Information has been received from a Certified Medical Assistant concerning a 24 year old female patient with neurocardiogenic syncope who on 21-NOV-2006 was vaccinated IM with her first dose of Gardasil, lot #653938/0954F. Concomitant therapy included INDERAL. On 21-NOV-2006 the patient experienced insomnia for one month following the administration of Gardasil. She later had the flu from being run down and lack of sleep. Unspecified medical attention was sought. The patient was reported as recovered. Additional information has been requested. Inderal Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Syncope UNK


Page 1049
Onset Date Unknown
Days
State FL
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Vomiting
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently the patient became dizzy and had some vomiting. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1050
Days 0
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthenia, Body temperature increased, Dizziness, Myalgia, Rash
Symptom Text: Initial and follow up information has been received from an LPN and the mother of a 12 year old female patient with aortic insufficiency and migraine headaches who on 01-FEB-2007 was vaccinated IM with her first dose of Gardasil, lot #654741/0013U. There was no concomitant medication. Subsequently, the patient experienced dizziness and developed an elevated temperature. It was also reported that the patient felt weak and had muscle aches for several days. The side effects eventually disappeared. However on 21-FEB-2007, the patient woke up with breast rashes. As of 21-FEB-2007 breast rashes persisted. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Aortic incompetence, Migraine UNK


Page 1051
Days 0
State NJ
Prev Doses 0
ER VISIT, NOT SERIOUS Injection site rash, Rash
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female with a penicillin allergy. On 01-FEB-2007, at 11:00 AM, the patient was vaccinated in the left arm with the first 0.5 mL dose of HPV (lot# 655619/1427F). Concomitant therapy included Yasmin. On that same day, at 4:00 PM, the patient developed a rash on her left arm from the injection site to the elbow and a rash also on her right arm (unspecified where on her right arm). The patient sought unspecified medical attention. The physician prescribed over-the-counter Benadryl and contacted the patient the next day for follow up. The patient reported that she was fine. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Penicillin allergy


Page 1052
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Eye movement disorder, Incorrect dose administered, Medical device complication, Tremor
Symptom Text: Information has been received from a licensed practical nurse concerning a 15 year old female who on 05-FEB-2007 was vaccinated with a dose of HPV (lot# 654540/1162F). On 05-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient's arm some of the liquid sprayed on the table and on the wall. The patient was not re-activated because of her reactions which were she "felt woozy" and her eyes were fluttering, and her whole body was shaking. It was noted that the patient did not lose consciousness. The patient will come back in two months to get re-vaccinated. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1053
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Flushing, Hot flush
Symptom Text: Information has been received from medical assistant via a company representative concerning the 26 year old female medical assistant who, on an unspecified date, was vaccinated with a dose of HPV. The medical assistant reported that after her vaccination with HPV, "her face turned very red and hot". The medical assistant recovered on an unspecified date. The patient (medical assistant) sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1054
Days 2
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Contusion
Symptom Text: Information has been received from a medical assistant concerning a 16 year old female who on 29-JAN-2007 was vaccinated IM in the right arm with a first 0.5mL dose of HPV. There was no concomitant medication. On approximately 31-JAN-2007 the developed bruises located on her right forearm and right upper arm. The reporter stated that "the patient noticed the bruises 2 days after the day of vaccination." At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1055
Days 0
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site mass
Symptom Text: Information has been received from a registered nurse concerning a female who on 06-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml), intramuscularly. On 06-JAN-2007 the patient had a lump at injection site. It was reported that one month later the patient still had lump at injection site. Unspecified medical assistant was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1056
Days 0
Received Date 16-Mar-2007 Lot NULL NULL NULL
State --
Manufacturer AVENTIS PASTEUR UNKNOWN MANUFACTURER MERCK & CO. INC.
Prev Doses
ER VISIT, NOT SERIOUS Abdominal pain, Arthralgia, Decreased activity, Diarrhoea, Dyspnoea, Dysuria, Epigastric discomfort, Headache, Nausea, Neck pain, Pain in extremity, Paraesthesia, Sinusitis, Vision blurred, Vomiting
Symptom Text: Information has been received from a pharmacy student concerning a 16 year old female who on December 2006, was vaccinated IM with a first 0.5 ml dose of HPV. Concomitant therapy included given the same day included a dose of influenza and a dose of Menactra. Seven days after vaccination, the patient experienced headache, nausea, vomiting and diarrhea. The patient was treated with Nexium and Phenergan tablets/suppositories. On 13-DEC-2006 the patient experienced a sinus infection and was placed on a Z-pack. All symptoms resolved except the headache. On 19-JAN-2007, the patient was seen by a neurologist and was placed on Prednisone for 10 days. He also ordered Tazepam to help her sleep since the headaches were keeping her awake and Endocet for the headache pain. The patient has missed a lot of school and is sedentary. She was also complaining of tingling in the hands and legs. The following tests have come back negative: CAT scan, MRI, Lyme and "mono" workup. At the time of this report, the patient had not recovered from tingling in the hands and legs and headache. No product quality complaint as involved. Additional information has been requested. 04/10/07-records received from neurologists for DOS 2/6/07-DX: muscular headaches with some functional overlay. Doubt side effect of Gardasil. C/O headaches, back pain, GI problems recent urinary symptoms, difficulty urinating and dysuria. C/O visual symptoms including blurry vision and spots before her eyes. PE: pain in neck, pain with deep palpation of right popliteal fossa. Walks normally. 05/01/07-records received from facility for DOS 02/09-02/12/07-DC DX: Vomiting and Abdominal Pain. HX 2month of chronic somatic complaints including nausea, epigastric discomfort, diffuse soft tissue and joint pain, vomiting, periodic shortness of breath and recent urinary symptoms. Labs, liver enzymes elevated in context of multiple Tylenol usage as an outpatient due to her pain.Hospital course included discontinuance of Tylenol and Percocet. LFTs steadily trended downward and sh Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: computed axial, 12/06; magnetic resonance, 12/06 records received 5/1/07-MRI negative, lab work normal. CT head and MRI of head negative. Normal abdominal ultrasound. Doppler normal of kidneys, normal upper GI series. negative lyme, negati UNK


Page 1057
Days 0
State IL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia, Paraesthesia oral
Symptom Text: Information has been received from a physician concerning a 20 year old female with allergy to unspecified medications who in approximately December 2006, around 2 months ago, was vaccinated with the first dose of HPV (lot #not reported). Concomitant medications were unspecified. In approximately December 2006, five minutes after receiving the first dose of the vaccine, the patient experienced tingling around her mouth and numbness that lasted for 20 minutes. The patient sought medical attention. The patient was then sent home and had no further problems. The patient did not continue the vaccination series because of the reaction. At the time of reporting, the patient had recovered. No further information was available at the time of reporting. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Drug hypersensitivity


Page 1058
Days 1
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Chills, Nausea, Vomiting
Symptom Text: Information has been received from a certified medical assistant concerning a 24 year old female that works in the same office On 05-FEB-2007, the patient was vaccinated with a first dose of HPV. There were no concomitant medications. On 06-FEB-2007 the patient developed severe nausea, vomiting and chills. Unspecified medical attention was sought. At the time of the reporter, the patient's outcome was unknown. Additional information has been requested. NONE Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1059
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pain, Presyncope
Symptom Text: Information has been received from a certified medical assistant (C.M.A) concerning approximately 19 female patients who were vaccinated with 0.5 mL dose of Gardasil (yeast). (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. The C.M.A also reported that another patient experienced pain at the injection site lasting for about a week and reported that she almost passed out from the pain (WAES0702USA04000). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1060
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site erythema, Swelling
Symptom Text: Information has been received from an office manager who was the mother of an 18 year old female patient with an unspecified auto immune disorder who in approximately February 2007 was vaccinated with a dose of HPV. The patient developed a "huge" red circle a few inches in diameter on her arm where she was vaccinated. There was a "lot" of swelling and the patient put ice on it all week. Medical attention was sought. The patient was recovering as of the report date. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Autoimmune disorder


Page 1061
Days 10
State NC
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician, via a company representative concerning a 25 year old female with a history of allergies to "many products," who on 26-JAN-2007 was vaccinated with the first dose of Gardasil (yeast). On 05-FEB-2007 the patient called the physician after she developed hives. The patient believed the hives were "caused by the vaccination," though the development and timing of the onset of the hives was unclear. The patient was instructed to take BENADRYL as treatment. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Multiple allergies NONE


Page 1062
Vaers Id: 274134-1 Age Gender F Unknown VAX Detail: Type MNC HPV4
Days 0
Received Date 16-Mar-2007 Lot NULL NULL
State CT
Prev Doses
ER VISIT, NOT SERIOUS Deafness, Dizziness, Injection site pain, Sudden hearing loss
Symptom Text: Information has been received from a registered nurse, via a company representative, concerning a female who on 05-FEB-2007 was vaccinated with a dose of Gardasil (yeast) in one arm and possibly a meningococcal vaccine (unspecified) in the other arm. Subsequently the patient felt faint, experienced a temporary loss of hearing, and also experienced pain from the injection. The nurse indicated that the patient's "fair hair (red or blonde) made them more susceptible to the adverse events." The patient was observed in the office and after a short time recovered and left. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1063
Days 1
State FL
Prev Doses 0
ER VISIT, NOT SERIOUS Blister, Pain Appears to be lower than site of injection. Patient denies other injury. Treated with tylenol #3 and omnicef.
Symptom Text: Blister, area looks burned. Pain at blistered site. Will follow up with doctor next week. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: N/A None None


Page 1064
Days 0
State MD
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site pain, Injection site swelling
Symptom Text: Patient Seen on 3/14/07 for complaints of pain and swelling at the site of the Gardasil vaccine given on the left upper arm. Injection administered on 3/8/07 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None - Was here for a physical/Well check Psych meds not prescribed by this MD


Page 1065
Days 0
State CA
Prev Doses 1
ER VISIT, NOT SERIOUS Injection site swelling, Rash generalised, Similar reaction on previous exposure to drug, Swelling face, Urticaria
Symptom Text: Received Gardasil #2, developed swelling around injection site after 2-5 minutes. That evening she developed hives on body and extemities-Mom gave Benadryl. Rash subsided but left side of face swollen but improved later in the day. 2 months ago 1st Gardasil given; she developed hives. Mom thought it was due to other allergies. Has been getting all over rash and swollen face since then. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1066
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site rash, Rash generalised
Symptom Text: Information has been received from a registered nurse, concerning a 13 year old female with multiple allergies, who on 23-JAN-2007 was vaccinated IM in the right arm, with the first dose of Gardasil (yeast) (Lot # 655165/1425F). There was no concomitant medication. Approximately five to ten minutes later, the patient developed a rash that "started at the injection site and then spread to the arm and the whole body." Treatment with ZYRTEC was immediately given in the office, and the patient was instructed to take BENADRYL at home, if needed. The nurse reported that "rash was mild and self-limiting," and remarked "it was easily treated with antihistamine and resolved soon after treatment was given." He clarified that "this was a mild reaction," and he did not feel the patients condition would have required hospitalization or threatened her safety. The mother of the patient wanted her daughter to receive the subsequent doses of the vaccine, however the nurse stated he felt the patient's system was "sensitized" and believed a second dose would be "too risky." Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Multiple allergies NONE


Page 1067
Days 1
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Muscular weakness, Myalgia, Nausea, Pyrexia, Rash
Symptom Text: Initial and follow up information has been received from a physician via a company representative, and the mother if the patient, concerning a 12 year old female who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (yeast). On approximately 02-FEB-2007 (within 24 hours), the patient developed nausea, a low grade fever, and experienced "muscle weakness that hurt." On approximately 06-FEB-2007 ("lasted for 4-5 days"), the patient recovered. Follow up information received from the mother of the patient, reported that on the morning of 21-FEB-2007, her daughter woke up with " a rash on her breasts, looks like pimples." The mother reported her daughter did not experience fever or itching with the rash, and the rash was "not on any other part of her body." The mother added that her daughter went to school, but "has not recovered from the rash." The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1068
Days
State NY
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Pyrexia
Symptom Text: Information has been received from a nurse concerning a female who was vaccinated with Gardasil. Subsequently, "within last week or week and a half," the patient developed a fever and was admitted to the hospital for 24 hours. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1069
Days 0
State IL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Chest pain
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female, with no pertinent medical history with allergies to erythromycin and sulfamethoxazole (+) SEPTRA who on 06-FEB-2007 was vaccinated with Gardasil (yeast), (Lot # 654885/1424F). There was no concomitant medication. On 06-FEB-2007 the patient developed chest pain when taking deep breaths. No other symptoms. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic reaction to antibiotics NONE


Page 1070
Days 0
State MT
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Incorrect route of drug administration, Injection site pain
Symptom Text: Information has been received from a licensed practical nurse concerning a female (age not reported) who in December 2006, was vaccinated with Gardasil (yeast) which may have been given by the SQ route or a partial SQ route. Subsequently, the patient developed slight injection site soreness (date unknown). The nurse reported that the nurse who administered this vaccination was left handed and his technique appeared "odd" and it may have looked like a SQ injection when it was really intramuscular. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1071
Onset Date Unknown
Days
State CA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a female medical assistant who was vaccinated IM, into the arm, with a first dose of Gardasil (yeast). Subsequently the patient experienced had pain in the arm that lasted a few minutes after vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1072
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Anxiety, Dizziness, Hyperhidrosis
Symptom Text: Information has been received from a nurse practitioner concerning a 15 year old female who was vaccinated IM with a first dose of Gardasil (yeast) (lot# 653938/0954F). Subsequently, the patient experienced diaphoresis, and felt faint moments after the injection. The patient;s lungs were clear and her pulse was 82. The patient went to the emergency room and was evaluated as being normal. The patient was released from the emergency room; however, the patient went to her primary care physician for evaluation. The physician determined that the patient was fine. The patient's mother called the nurse practitioner and said that her daughter gets extremely anxious with injections which may have contributed to the symptoms. In addition, the patient also had an empty stomach at the time of vaccination. The patient's mother and the felt that the patient is eligible to receive the subsequent doses of the vaccine. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: respiratory rate - clear, total heartbeat count - 82 UNK


Page 1073
Days 0
State --
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Dizziness, Erythema, Hypoaesthesia, Injection site pain, Local reaction
Symptom Text: Information has been received from a health professional concerning a 16 year old female with no medical history who on 06-FEB-2007 was vaccinated IM in to the right deltoid with a 0.5 ml dose of Gardasil (yeast) (lot # 654535/0960F). There was no concomitant medication. On 06-FEB-2007 after vaccination the patient developed a local reaction. She experienced 30 seconds of dizziness. The local reaction started with pain at the injection site that radiated down her arm and her entire arm was red. After the patient subsided the arm went numb and then the patient was fine. The entire episode lasted only 5 minutes and the patient seemed fully recovered. Additional information is not expected. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1074
Onset Date Unknown
Days
State PA
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second of Gardasil (yeast). Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1075
Days 0
State VA
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Head injury, Inappropriate schedule of drug administration, Loss of consciousness
Symptom Text: Initial and follow up information has been received from a licensed practical nurse via a company representative, concerning a 12 year old white female student, who on 06 Nov 2006 was vaccinated in the right deltoid with 0.5 ml of the first dose of Gardasil. There was no concomitant medication. There was no illness at the time of vaccination. The patient passed out in the physician's waiting room after receiving the vaccination. The patient stated she did not eat breakfast. Upon awakening, the patient was given crackers and soda, and stated she felt better. On 05 Feb 2007, three months after the first dose, the patient was vaccinated in the left deltoid with the second dose of Gardasil. After the second vaccination, the mother called and reported her daughter had passed out at home and hit her head. The patient did not receive medical attention, but her physician was informed. The patient recovered the same day, 05 Feb 2007. Additional information is not expected. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1076
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pruritus, Rash generalised
Symptom Text: Information has been received from a physician via a company representative, concerning a 19 year old female who on 07 Feb 2007 was vaccinated with an 0.5 ml dose of Gardasil. By the evening of the same day, the patient developed a "rash from head to toe and itching." The patient has not recovered at the time of this report. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1077
Days 365
State MD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fungal infection
Symptom Text: Information has been received from a 22 year old female health professional who on 25 Jan 2006 was vaccinated with a first dose of Gardasil. The patient reported that within 24 hours of vaccination she experienced a yeast infection. It was reported that the patient sought medical attention for this event. The patient recovered after approximately 2 days. Patient would complete her vaccination series. Additional informatio has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1078
Days 0
State MD
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Syphilis test positive
Symptom Text: Information had been received from a physician and a Registered Nurse concerning a 16 year old female who was sexually active. In August 2006, the patient was vaccinated with the first dose of Gardasil, at the end of November 2006 with the second dose. She received the vaccination at the pediatrician's office. The patient was tested for syphilis " a couple of days" later. The patient's Rapid Plasma Reagin (RPR) test titers were 1-256 (high), with a negative Fluorescent Antibody Absorption (FTA) test. The patient was tested again approximately one week later and the RPR titers were still high but lower. The physician mentioned that the patient underwent other antibody tests such as serum antinuclear antibodies (ANA) test, and Lyme disease test. The results were normal for those tests. The physician stated that the patient had not been sick with the flu nor mononucleosis, and that the patient had tested negative for other sexually transmitted diseases. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Diagnostic laboratory, 11/06, negative, sexually transmitted disease; lyme disease assay, 11/06, Normal; rapid plasma reagin, 11/06, 1-256, High; serum ANA, 11/06, Normal; rapid plasma reagin, 11/06, positive but lower; FTA-ABS, 11/06, Nega sexually active


Page 1079
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Diarrhoea, Lethargy, Nausea, Pseudomononucleosis
Symptom Text: Information has been received from a health professional concerning a 15 year old female on 13 Nov 2006 was vaccinated with a first dose of Gardasil. There were no concomitant medications. On approximately 13 Nov 2006 the patient experienced nausea, lethargy and "mono like symptoms." Subsequently, the patient recovered. On 03 Feb 2007, the patient was vaccinated with a second dose of Gardasil. On 03 Feb 2007 the patient experienced nausea, marked lethargy, "mono like symptoms" and diarrhea for 2 days after the vaccination. On 05 Feb 2007, the patient returned to the doctors office and underwent a complete blood cell count and an Epstein-Barr virus antibodies screen. It was reported that "mono" was ruled out. At the time of the report, the patient was recovering. Additional information has been requested. NONE Other Meds: Epstein-Barr virus, 2/5/07; complete blood cell, 2/5/07 Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1080
Vaers Id: 274194-1 Age Gender F Unknown VAX Detail: Type MEN HPV4
Days 0
State CT
Prev Doses
ER VISIT, NOT SERIOUS Dizziness, Injection site pain, Sudden hearing loss
Symptom Text: Information has been received from a registered nurse, via a company representative, concerning a female who on approximately 31 Jan 2007 was vaccinated with a dose of Gardasil in one arm and possibly a meningococcal vaccine (unspecified) in the other arm. Subsequently the patient felt faint, experienced a temporary loss of hearing, and also experienced pain from the injection. The nurse indicated that the patient's "fair hair (red or blonde) made them more susceptible to the adverse events." The patient was observed in the office and after a short time recovered and left. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1081
Days 0
State PA
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 21 year old white female with no known drug allergies or illness at the time of vaccination who on 01 Jan 2007 was vaccinated in the right deltoid with a 0.5 mL first dose of Gardasil. Concomitant therapy included Yaz, Zelnorm and Miralax. On 04 Jan 2007, the patient became lightheaded and had to lie down after receiving Gardasil vaccination. The patient stated that she had gotten lightheaded after injections in the past. She also did not have much to eat that morning. The patient did not lose consciousness and remained alert and responsive. The patient was given some peanut butter crackers and coke and subsequently felt better and recovered. Additional information is not expected. Yaz, Miralax, Zelnorm Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK dizziness


Page 1082
Days 0
State WI
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 26 Jan 2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil. On 26 Jan 2007 the patient developed a rash at her injection site. The patient sought unspecified medical attention. On 27 Jan 2007 the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1083
Days 0
State TX
Prev Doses
ER VISIT, NOT SERIOUS Incorrect dose administered, Injection site reaction, Medical device complication, Pain in extremity, Skin irritation
Symptom Text: Information has been received from a licensed visiting nurse concerning a 14 year old female with no medical history and no known drug allergies, who on 08 Feb 2007 was vaccinated IM with a dose of Gardasil. Concomitant therapy included Ortho Tri Cyclen Lo and Synthroid. The patient inadvertently received less than the recommended dose and experienced an injection site reaction. The nurse withdrew the vaccine from a vial and the medication leaked near the hub of the syringe while administering it to the patient. The patient complained of irration on the left deltoid about a two inch radius from the injection site. She also reported that the pain "ran down" her left arm. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Ortho Tri Cyclen Lo, Synthroid Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1084
Days 0
State IA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Dizziness, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Symptom Text: Information has been received from a licensed practical nurse concerning a female with pertinent medical history unspecified and drug reaction/allergies unspecified who in December 2006, two months ago, was vaccinated with first dose of Gardasil 0.5 ml IM. Concomitant therapy was unspecified. In December 2006, one day after receiving the injection, the patient experienced redness, swelling, itching, and bumps on her arm at the injection site. The patient also experienced light-headedness, and dizziness. The patient sought medical attention. Subsequently, the patient recovered. No other information was available at the time of reporting. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 1085
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from an office manager concerning a female (age not reported) with a history of passing out when receiving shots who on an unspecified date was vaccinated with Gardasil (lot # not reported) 0.5 ml injection. On an unspecified date, the patient passed out after the shot of Gardasil, unknown which dose. Unspecified medical attention was sought. The patient recovered later in the day. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: passed out


Page 1086
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a female receptionist who was vaccinated with a dose of Gardasil. Subsequently the injection site became swollen after a week, "about the size of a half dollar." It was reported that there were "rings around the swelling an it was painful. "Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1087
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Erythema, Pruritus
Symptom Text: Information has been received from a physician concerning a 16 year old female with asthma who in December 2006, was vaccinated with the first dose of Gardasil. Concomitant therapy included FLOVENT, albuterol and ZYRTEC. In December 2006, a few hours following vaccination with Gardasil, the patient experienced itchiness and redness of her face. The patient sought unspecified medical attention. Subsequently on an unspecified date, the patient recovered from itchiness and redness of her face. Additional information has been requested. albuterol, Zyrtec, Flovent Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma


Page 1088
Days 0
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site pain, Injection site reaction
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on 26-NOV-2006 was vaccinated with the first dose of Gardasil and on 31-JAN-2007 was vaccinated with the second dose of Gardasil. Concomitant medication was not reported. On approximately 26-NOV-2006 the patient experienced headache after the first dose of Gardasil, which lasted about one month. The outcome and causality of the headache was not reported. On 07FEB-2007, about 7 days after the second dose of Gardasil, the patient developed a "lump," redness and pain in her arm, at the injection site. The physician reported that the injection site reaction was approximately one half centimeter which was extremely tender and painful. On an unspecified date, the patient sought unspecified medical attention. The patient's events persisted. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1089
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Burning sensation, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 26 female who in August 2006, "in the morning" was vaccinated with Gardasil. By nighttime, the patient experienced burning sensation in cheeks. The next morning she developed an itchy rash on her cheeks. The patient sought unspecified medical attention. Subsequently, the patient recovered from burning sensation in cheeks and itchy rash on her cheeks. Additional information has been requested. UNK Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1090
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a female (age unknown) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. The patient was administered Gardasil in one arm ant Tetanus vaccine in the other arm on the same day. On approximately 02-FEB2007 the patient developed a rash on her whole body. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 1091
Onset Date Unknown
Days
State MI
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced dizziness and sought unspecified medical attention. No further information was provided. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1092
Days 19
State CA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Injection site bruising, Injection site rash, Nausea
Symptom Text: Information has been received from a registered nurse via a company representative, concerning a 25 year old female who on approximately 22-JAN-2007 (about three weeks ago), was vaccinated with the second dose of Gardasil, 0.5 ml. Concomitant therapy included ZELNORM. On approximately 10-FEB-2007 ("within the past day or two"), the patient developed "a bump and bruise at injection site, and nausea. It was reported that the patient had "no ill effects after the first dose" (date not provided). At the time of this report, the patient had not yet recovered. The patient sought unspecified medical attention. Additional information has been requested. Zelnorm Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 1093
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Sensory disturbance
Symptom Text: Information has been received from a nursing supervisor concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Subsequently, the patient reported that her arm felt dead. At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1094
Onset Date Unknown
Days
State FL
Prev Doses 0
ER VISIT, NOT SERIOUS Influenza like illness
Symptom Text: Information has been received from a physician concerning an 11 year old female who on 08-FEB-2007 was vaccinated with her first dose of Gardasil and experienced flu-like symptoms after the vaccination. Concomitant therapy included Menactra. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1095
Days 5
State NJ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthenia, Fatigue, Nausea, Pain, Wrong drug administered
Symptom Text: Information has been received from the mother of an 11 year old male with severe acid reflux and possibly a hiatal hernia, severe allergies to many different things such as pollen, dust, and various foods, mild asthma, anxiety problems and a history of seizure as an infant after DPT vaccination, who on 07-FEB-2007 was vaccinated with a dose of Gardasil by mistake. Concomitant therapy included ZYRTEC, PAXIL, PRILOSEC and different allergy shots. The report stated that her son was supposed to have received an unspecified hepatitis vaccine. On 12-FEB-2007 the patient was feeling achy, weak, tired and nauseous. She also stated that she was not sure that these symptoms were related to the vaccine. Medical attention was sought. The patient was reported as not recovered at the time of this report. Additional information has been requested. Allergenic extract, Zyrtec, Prilosec, Paxil Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Convulsion Pollen allergy, House dust allergy, Food allergy, Acid reflux (Oesophageal), hypersensitivity, asthma, anxiety disorder.


Page 1096
Days 1
State FL
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a 14 year old female patient with possible allergy to penicillin and erythromycin who on 03-JAN2007 was vaccinated with a first dose of Gardasil (yeast), lot # 653938/0954F. The patient was not on any medication. On 04-JAN-2007 the patient developed hives. The patient was examined by the physician on 05-JAN-2007. The patient was reported as completely recovered by 06-JAN-2007. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy; Allergic reaction to antibiotics UNK


Page 1097
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Muscular weakness, Tremor
Symptom Text: Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on approximately 09-FEB-2007 was vaccinated with first dose of Gardasil (yeast) (lot # not reported) 0.5 ml IM. On approximately 09-FEB-2007, the patient experienced dizziness, weakness and shaky legs after receiving Gardasil (yeast). Medical attention was sought. As a result of the symptoms, the patient was home from school for 3 days. At the time of reporting, the patient was recovering. No further information was available at the time of reporting. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1098
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse concerning a 26 year old female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient experienced "vomited eight hours with no fever". Subsequently, the patient recovered (date unspecified). No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 1099
Days 0
State WI
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Blood pressure increased, Dyspnoea
Symptom Text: Information has been received from a physician concerning a 23 year old female who in December 2006, was vaccinated with a second dose of Gardasil (yeast). In December 2006, the patient's blood pressure went up and she developed shortness of breath. After 30 minutes, the patient's blood pressure returned to normal. The patient was not pregnant. At the time of this report, the outcome of the shortness of breath was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1100
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug administered at inappropriate site, Malaise, Muscle tightness
Symptom Text: Information has been received from a "healthcare worker" concerning a female (patient 2 of 4), either 14 years or 17 years old, who was vaccinated with the first dose of Gardasil (yeast) 0.5 ml IM in the gluteal region. The patient experienced "knots in her neck and ill feeling" one to two weeks after receiving the vaccination. The healthcare worker noted that the patient was being treated for "something else that had absolutely nothing to do with the vaccination". This patient "had no problems". Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 1101
Days 3
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Injection site discolouration, Melanocytic naevus, Pain, Rash, Skin hyperpigmentation
Symptom Text: Information has been received from a physician concerning a 22 year old female with mild asthma and a history of CIN grade I (2003, 2005 and 2006) and a benign pigmented lesion removed from her inner thigh (2006) who on 08-FEB-2007 was vaccinated IM into the right arm with a 0.5 ml dose of Gardasil (yeast) (lot # 654535/0960F). Concomitant therapy included oral hormonal contraceptives (unspecified). Three on 11-FEB-2007 the patient developed two raised areas of hyperpigmented skin in the area of the injection site. The areas are 4 x 4 mm and 3 x 3 mm. The areas are described as are nevus like in appearance, linear, surrounded by erythema and painful. The patient is being evaluated for a "possible skin rash." The patient had not yet recovered from her experiences. Additional information has been requested. hormonal contraceptives Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Cervical intraepithelial neoplasia; Benign pigmented naevus excision Asthma


Page 1102
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of Gardasil (yeast) (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1103
Days 27
State MT
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Asthma exercise induced
Symptom Text: Information has been received from a certified medical assistant concerning her 11 year old daughter with no past medical history and no allergies who on 15DEC-2006 was vaccinated with a first dose of Gardasil (yeast), IM. There was no concomitant medication. On 11-JAN-2007 the patient experienced excerise induced asthma. The patient noticed that she was short of breath during exercise during sports. The patient had recovered without treatment on 30-JAN-2007. There were no relevant diagnostic tests or laboratory data. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1104
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician's assistant concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil (yeast) (lot # not reported) IM injection. Concomitant therapy was unspecified. The patient sought unspecified medical attention. Subsequently, the patient experienced an extreme rash across her chest and up to her neck. At the time of reporting, the patient was "fine". Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1105
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Alpha 1 foetoprotein abnormal, Drug exposure during pregnancy
Symptom Text: Information has been received from a licensed practical nurse (LVN) as part of the pregnancy registry concerning a 17 year old female with penicillin allergy and drug reaction/allergy to DARVOCET, and VICODIN. She had no other concurrent medical conditions, or significant past medical history including no history or pregnancies. On 17-OCT-2006, the patient was vaccinated with first dose of Gardasil (yeast) (lot # 654540/0800F also reported as 653937/0637F) 0.5 ml IM. There was no concomitant medication. The patient's last menstrual period was 18-OCT-2006. Medical attention was sought. On 11-DEC-2006, an ultrasound was performed that revealed pregnancy of 8 weeks and 2 days (estimated date of delivery 25-JUL-2007). On approximately 11-DEC-2006, maternal serum alpha-fetoprotein (MSAFP) test was performed that indicated the baby was at increased risk (positive) for neural tube defect (NTD). Medication taken during the pregnancy included prenatal vitamins. The patient was scheduled for follow-up testing with a perinatologist. No other information was available at the time of reporting. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 10/18/06), Penicillin allergy; Drug Hypersensitivity ultrasound 12/11/06 - prenatal testing: 8 weeks and 2 days, serum alpha-fetoprotein 12/11?/06 - positive screen for neural tube defect


Page 1106
Days 0
State PA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site pruritus, Pruritus generalised
Symptom Text: Information has been received from a consumer concerning her 18 year old old daughter with no pertinent medical history who on 26-JAN-2007 was vaccinated with her first dose of HPV. Concomitant therapy included hormonal contraceptives (unspecified). On 26-JAN-2007 the patient experienced itching at the injection site that developed into full body itching. Medical attention was sought. The patient was treated with Benadryl. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Her second dose was scheduled for 23-MAR-2007. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1107
Days 0
State ME
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Inappropriate schedule of drug administration, Injection site calcification, Injection site pain, Injection site pruritus
Symptom Text: Information has been received from a 35 year old female with no pertinent medical history who on 22-JAN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of HPV. There was no concomitant medication. On 31-JAN-2007 the patient developed a painful itch at the injection site. The patient reported that after careful study of the site, she noted and then felt a bump at the injection site. The patient consulted with her physician who stated it was a calcification. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1108
Days 11
State WV
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 24 year old female patient with Hyperlipidemia, polycystitis ovarian syndrome and penicillin allergy who on 31-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (lot# 654702/0011U), intramuscularly. Concomitant therapy included cholestyramine resin, atorvastatin calcium (Lipitor) and drospireneone + ethinyl estradiol (Yasmin). On 11-FEB-2007, the patient developed a maculopapular rash on her torso and bilateral upper extremities. The patient was evaluated at an urgent care facility and was prescribed a Prednisone pack. At the time of the report the patient was considered to be not recovered. Unspecified medical attention was sought. Additional information has been requested. Lipitor, Cholestryramine Resin, Yasmin Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Hyperlipidaemia; Ovarian cyst; Penicillin allergy


Page 1109
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician's assistant concerning a 23 year old female with genital warts who in December 2006, was vaccinated with first dose of HPV (lot # not reported) 0.5 ml injection. Concomitant therapy was unspecified. The patient sought medical attention. In December 2006, after taking the first dose of vaccine, the genital warts seemed to worsen. The patient was treated with thioguanine and cytarabine (TCA). On approximately 07-FEB-2007, the patient was given the second dose of HPV (lot # not reported) 0.5 ml injection. The outcome of the worsening genital warts was not specified. No further information was provided at the time of reporting. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1110
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Diarrhoea, Rash generalised
Symptom Text: Information has been received from a nurse practitioner concerning her 17 year old daughter with attention deficit/hyperactivity disorder and a history of shellfish allergy (as a child: outgrew) who in November 2006, was vaccinated in the right deltoid, IM with a first dose of HPV (Lot # not reported). Her second dose of HPV (Lot # 653650-0640F) was administered IM into the right deltoid in January 2007. Concomitant therapy included Adderall. The nurse practitioner reported that 3 days after each dose of HPV, her daughter developed diarrhea (unspecified dates in November 2006 and January 2007). The diarrhea was reported to be "relatively severe and spontaneously resolved". On an unspecified date in January 2007, on the fourth day after the second dose, the patient "developed a rash on her knees and thigh that spread during the day until she was covered in a rash from her neck to her feet." She was treated with Benadryl and it resolved. The reporter noted that the decision was made to discontinue the series so a third dose would not be given. The patient sought unspecified medical attention. Additional information has been requested. Adderall Tablets Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Shellfish allergy; Attention deficit/hyperactivity disorder


Page 1111
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female who was vaccinated with a first dose of HPV. Subsequently the patient experienced nausea and vomiting. At the time of the report the patient was recovering. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1112
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Crying, Pain
Symptom Text: Information has been received from a nurse practitioner and a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of HPV. Subsequently, the patient ended up crying and reported she had pain, when the vaccine was being administered, either left or right arm and had some pain afterwards. The licensed practical nurse further reported that the patient developed pain one hour after the injection. The patient reported that the pain had subsided, however, when the patient went to bed that evening, the pain had returned. Unspecified medical attention was sought. At the time of this report, the patient had fully recovered from the events (date unknown). Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1113
Days 0
State MN
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Hyperhidrosis, Nausea, Pyrexia
Symptom Text: Information has been received from a nurse concerning a 21 year old female with no past medical history who on 04-DEC-2006 was vaccinated with HPV (lot # 654510/0962F), intramuscularly. There was no concomitant medication. On 04-DEC-2006, "five hours after vaccination", the patient felt feverish plus experienced dizziness and nausea and diaphoretic. The patient went to bed that evening and the next morning symptoms had resolved. Unspecified medical attention was sought. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1114
Onset Date Unknown
Days
State OR
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age not reported) with established papilloma viral infection and a colposcopy was performed who on an unspecified date was vaccinated with HPV (lot# not reported). Subsequently, the patient experienced an outbreak of genital warts. Medical attention was sought. The outcome of the genital warts was not reported. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1115
Onset Date Unknown
Days
State NC
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a LPN concerning a 25 year old female patient with sulfonamide allergy and allergic reaction to Biaxin who on 26-JAN-2007 was vaccinated IM in right deltoid with her first dose of Gardasil, lot #654702/0011U. She developed generalized hives after the vaccination. The nurse did not know when the hives started. Benadryl was recommended as treatment. The outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Sulfonamide allergy and allergic reaction to antibiotics.


Page 1116
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Fatigue, Nausea, Urticaria, Wheezing
Symptom Text: Information has been received from registered nurse supervisor, via a company representative, concerning a 12 year old patient who on 13-FEB-2007 was vaccinated IM in the left deltoid a 5:00 pm with the first dose of Gardasil. Three hours later (8:00pm), the patient had developed hives on the face, back and bottom. By 8:30pm, the patient began to experience wheezing, but then "slept fine through the night". Treatment was not specified. The next morning (14-FEB2007), hives "had subsided," but the patient "felt nauseous and tired." At the time of this report, the patient had not recovered. The nurse also reported that the patient will not be given the second and third dose of the vaccine. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1117
Days 0
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Confusional state, Fall, Head injury, Subarachnoid haemorrhage, Syncope
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 15-FEB-2007 was vaccinated with Gardasil (lot # 654672/0444F). There was no concomitant therapy. On 15-FEB-2007, 2-3 minutes after Gardasil injection the patient experienced syncopal episode, fell and hit her head. The patient had a head injury and central lateral subarachnoid bleeding and was hospitalized. The patient's syncopal episode and head injury and central lateral subarachnoid bleeding persisted. It was reported that the patient had a gradual clearing of confusion. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1118
Days 0
State TX
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Chest discomfort, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site rash, Rash, Rash
Symptom Text: Information has been received from a health professional concerning a 20 year old female with no pertinent medical history who on 05-FEB-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil (lot #653650/0702F). There was no concomitant medication. In February 2007, after the vaccination, the patient experienced an "allergic type reaction." The patient developed red raised bumps and itching at the injection site. It was reported that a rash spread to her arms, trunk and legs and the patient experienced a tight chest (she was able to breathe). Medical attention was sought and the patient was treated with a MEDROL DOSEPAK. There were no laboratory or diagnostic tests performed. On 14-FEB-2007, the patient fully recovered. The registered nurse considered red raised bumps and itching at the injection site, rash spread to her arms, trunk and legs and tight chest to be other important medical events. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1119
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS Paraesthesia, Paraesthesia
Symptom Text: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who in February 2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. Approximately two weeks post vaccination, the patient experienced paresthesia of hands and feet and was hospitalized. The patient was in the hospital for approximately 5 days and was treated with immune globulin. The physician reported that "blood studies" and "agency reported" had normal results. The patient was discharged from the hospital and had subsequently fully recovered. The reporting physician considered paresthesia of hands and feet to be disabling and an other important medical event. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: complete blood cell - normal results, hematology - normal results NONE


Page 1120
Onset Date Unknown
Days
State CA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Injected limb mobility decreased, Musculoskeletal pain
Symptom Text: Left should still in pain one week after injection. No swelling, no redness. Seen by doctor today for follow up. Unable to lift arm completely. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 1121
Days 0
Received Date 19-Mar-2007 Lot 0188UU
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Feeling jittery, Pallor, Paraesthesia, Throat irritation
Symptom Text: Pt called on-call doctor, complaining of tingling in her fingers, pressure in her throat, pale and jittery. He instructed her to go to Emergency room. Pt did not go. When we reached her she said she felt fine by the next morning. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergy to Sulfa and Amoxicillin NONE


Page 1122
Days 4
State MA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Fatigue, Feeling abnormal, Hypoaesthesia, Loss of consciousness, Paraesthesia
Symptom Text: About 3rd day after receiving HPV #2 got up at night (early AM) and was looking in mirror trying to adjust nose ring-became frustrated at fit and put swollen ring back in. On way back to bed, felt numbness and tingling in legs, then "blacked out" few minutes as friend woke her up-felt tired all day. Later afternoon, took shower and went up to room didn't "feel right" and had tingling and numbness of legs and arms for 5-10 minutes-resolved. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 1123
Days 0
State ND
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Asthenia, Dizziness, Feeling cold, Feeling hot, Loss of consciousness
Symptom Text: Approx 20 min after vaccine pt felt dizzy, weak and blacked out. Caught by mother before falling to ground. Also felt hot. Taken home (was at grocery store). Felt slightly weak and then at 9 pm that night felt very cold and weak at 9pm. No rxn at injection site. Ortho Lo birth control Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1124
Days 4
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fatigue, Injection site erythema, Injection site swelling, Pain in extremity, Tonsillar hypertrophy
Symptom Text: Information has been received from a physician concerning a 16 year old female patient who on 15-JAN-2007 was vaccinated with her first dose of Gardasil. On 19-JAN-2007 the patient developed red and swollen arm in the injection area. The physician advised patient to take Tylenol. On 22-JAN-2007 the patient reported that her tonsils were swollen. She felt really tired and that her leg was hurting and she could not put weight on it. The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1125
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Eating disorder, Loss of consciousness, Syncope
Symptom Text: Information has been received from a nurse concerning a 25 year old female who on 02-FEB-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (lot #655503/012U). Concomitant therapy included Depo-Provera. Illness at the time of vaccination included flu-like symptoms. Immediately after vaccination, the patient had syncope and passed out for approximately one minute. It was also noted that her eating was sporatic. The patient has not passed out with previous injections in the past. The physician did not believe the injection cause the syncope. Unspecified medical attention was sought. On 02-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested. Depo-Provera Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Immunisation Flu Symptoms


Page 1126
Days 0
State MO
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure fluctuation, Drug administered at inappropriate site, Headache, Hyperventilation, Malaise, Migraine
Symptom Text: Information has been received from a health professional concerning a 15 year old female with no medical history, who on 12-FEB-2007 at 15:30 was vaccinated IM with a second dose of Gardasil (lot# 653978/0955F). Concomitant therapy included ORTHO TRI-CYCLEN LO, BENADRYL and TYLENOL EXTRA STRENGTH. Illness at the time of vaccination included bronchitis. It was noted that the patient may have not eaten all day. "At the patient's request she received the vaccination in her glut." After 2 to 3 minutes, the patient felt sick and began to hyperventilate. The patient's blood pressure went up and down and she complained of a left-sided headache. The patient was diagnosed with a migraine. It was noted that the patient was sent to the emergency room. A "CT of her head" was performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. ORTHO TRI-CYCLEN LO, BENADRYL, TYLENOL EXTRA STRENGTH Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: head computed axial NONE Bronchitis


Page 1127
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (age unknown) who on an unspecified date was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, on an unspecified date, the patient passed out. The patient sought unspecified medical attention. subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1128
Onset Date Unknown
Days
State SC
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Loss of consciousness
Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with Gardasil (conflictingly reported oral route). Reportedly. the patient passed out. At the time of the report, it was unknown if the patient recovered. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1129
Onset Date Unknown
Days
State DC
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Incorrect dose administered, Injection site extravasation, No adverse effect, Underdose
Symptom Text: Information has been received from a physician concerning a patient who on 15-FEB-2007 was vaccinated, intramuscularly, into the deltoid muscle with the first 0.5 ml dose of Gardasil (lot not reported). It was reported that during the administration of the first dose there was some leaking of the vaccine at the injection site. The patient was not able to receive the complete dose. No adverse experience related to this event. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1130
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Nausea
Symptom Text: Information has been received from a physician's assistant concerning a female (age not reported) who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported) IM. The patient reported feeling nauseous in between the first and second dose of vaccine. Medical attention was not sought. The outcome of the nausea was not reported. No additional information was provided at the time of reporting. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1131
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a family nurse practitioner (FNP), the consumer, a mid thirties year old female who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported). Subsequently, the patient experienced stinging after the vaccination. The patient also reported that her arm was sore and stung more after the second and third vaccination with Gardasil. The patient sought medical attention. At the time of reporting, the patient had recovered. No other information was available at the time of reporting. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1132
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pharyngolaryngeal pain, Pyrexia
Symptom Text: Information has been received from a nurse concerning a 17 year old female patient with pertinent medical history and drug reactions/allergies reported as unspecified on 23-JAN-2007 was vaccinated with Gardasil (lot # not reported) injection. On an unspecified date, the patient went to the hospital with a sore throat and a fever of 100 degrees. After receiving the Gardasil injection, her temperature went to 104.8 degrees on 23-JAN-2007. The physician administered antibiotics for her sore throat. The outcome of the events was unspecified. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: temperature measurement 01/23/07 100, temperature measurement 01/23/07 104.8 UNK


Page 1133
Days 0
State MA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Arthralgia, Arthralgia, Arthralgia
Symptom Text: Information has been received from a nurse practitioner concerning a 13 year old female who in January 2007, was vaccinated with Gardasil. In January 2007, the patient developed arthritic symptoms. The patient had developed achy knees and wrists. There was no redness on the knees and the wrists but were sore. It was reported that ibuprofen was little help in relieving the pain. The nurse practitioner reported that she would ask for lab work to be done for rheumatoid arthritis and a sedimentation rate. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the events. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1134
Onset Date Unknown
Days
State PA
Type VARCEL HPV4
Prev Doses
ER VISIT, NOT SERIOUS Varicella
Symptom Text: Information has been received from a physician concerning a female "between 12-14 years" old who on an unspecified date was vaccinated with Gardasil. That same day, concomitant suspect therapy included Varivax. On an unspecified date, eight days after administration, the patient developed a chicken pox rash. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1135
Days 0
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who on approximately 25-JAN-2007 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 25-JAN-2007 the patient experienced "delayed mensis." Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1136
Days 0
State MN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Adverse event, Dizziness, Pyrexia
Symptom Text: Information has been received from a registered nurse concerning a female who on approximately 15-DEC-2006 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 15-DEC-2006 the patient developed high fever, dizziness and "several adverse events." Unspecified medical attention was sought. At the time of the report, the patient was recovering and the physician discontinued further series of Gardasil. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1137
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash, Urticaria
Symptom Text: Information has been received from a female patient who was vaccinated with her first Gardasil and developed a rash on her thigh, hip and stomach. After receiving second dose of Gardasil the patient developed hives and a rash. The patient's outcome was unknown. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1138
Days 0
Received Date 13-Mar-2007 Lot U1968AA 1427F AHAVB143BA
State NJ
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Dyskinesia, Fall, Hyperhidrosis, Pain in extremity, Staring
Symptom Text: Information has been received from a licensed practical nurse concerning a 16 year old female student with no pertinent medical history who on 16-Jan-2007, at 14:45, was vaccinated, into the left deltoid, with a first dose of Gardasil (lot #655619/1427F) concomitantly with a first dose of Havrix (lot AHAVB143BA) in the left arm and a first dose of Menactra (lot U1968AA) into the right deltoid. On 16-Jan-2007, at 14:45, while sittings on table, the patient complained of severe pain in the left arm. As the patient was complaining, she fell forward, and the licensed practical nurse laid her down. The patient's eyes were fixed staring at the ceiling and her body started jerking wildly and thrashing. The patient went from jerking and trashing to "jumping up and asking what happened." The patient was guided back to the table and her body started jerking and thrashing with her eyes fixed on the ceiling and non-reactive. Subsequently, the patient came to diaphoretic. In January 2007, the patient recovered. No further information is available. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 1139
Onset Date Unknown
Days
State OK
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Menstrual disorder
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced her first menstrual cycle which was extremely heavy. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1140
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information had been received from a physician concerning a female (age unknown) who on an unspecified date was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, on an unspecified date, the patient passed out. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1141
Days 0
State MI
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Body temperature increased, Diarrhoea, Dizziness, Headache, Muscle spasms, Nausea, Pyrexia, Tachycardia, Vomiting
Symptom Text: Information has been received from a consumer's mother and physician concerning a 16 year old female with a MOTRIN allergy, and no medical history who on 10-FEB-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil. There was no concomitant medication. On 10-FEB-2007 (consumer's mother reports as 12-FEB-2007), the patient experienced "heart racing, nausea, dizziness, temp of 99.7 (consumer's mother reported as 101 deg F), cramps, vomiting, bad headache and diarrhea." The patient's mother reported that the patient "had been out of school all week and was not feeling well." She also stated that "there was a follow up visit with the physician who associated the experience with the vaccine and she was given a medicine for the nausea and cramps." At the time of this report, the patient had not recovered according to the consumer's mother. The physician reported that on 17-FEB-2007 the patient recovered from diarrhea, nausea, vomiting, cramping and low grade fever. No product quality complaint was involved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Drug Hypersensitivity body temp 02/10/07 99.7 degF - fever


Page 1142
Days 0
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 12 year female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2006 the patient fainted after the administration of Gardasil. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1143
Days 2
State CO
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 23 year old female with sulfonamide allergy and no pertinent medical history who on 20-OCT2006 was vaccinated with Gardasil. Concomitant therapy included YASMIN. On 22-OCT-2006, 48 hours after receiving the immunization, the patient developed itching without a visible rash. The patient sought unspecified medical attention. No laboratory tests were performed. The itching persisted for 3 weeks. At the time of reporting, the patient had recovered from the itching on approximately 10-NOV-2006. No other information was available at the time of reporting. Additional information has been requested. YASMIN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sulfonamide allergy NONE


Page 1144
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site erythema, Injection site pain, Injection site swelling
Symptom Text: Information has been received from a nurse practitioner concerning a 15 year old female with no pertinent medical history and no history of drug reactions/allergies who on 09-FEB-2007 was vaccinated with first dose of Gardasil (lot # 655617/1447F) 0.5 ml injection. There was no concomitant medication. On 09-FEB-2007, the patient experienced swelling, tenderness, and redness in the injection site after receiving her first Gardasil dose. The patient sought medical attention. The next morning, the clinic administered 50 mg of BENADRYL and "it went back to normal". The nurse practitioner did not mention if it was because of the diphenhydramine. Subsequently, the patient recovered. They plan to give the second shot. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1145
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient between the ages of 11 to 13 who within the last 3 months was vaccinated IM with a 0.5 mL dose of Gardasil. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1146
Days 4
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Skin papilloma
Symptom Text: Information has been received from a nurse via a company representative concerning a 26 year old female with a history of warts from childhood who on 02FEB-2007 was vaccinated with a first 0.5 mL dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). It was reported by the nurse that the patient informed the clinic that she had a breakout of warts in her forearm 4 days after vaccination, on 06-FEB-2007. At the time of the report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Wart


Page 1147
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with Gardasil (yeast). Subsequently the patient experience rash on back. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE UNK


Page 1148
Days 0
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Condition aggravated, Schizophrenia
Symptom Text: Information has been received from a physician concerning a 16 year old female with schizophrenia. On 31-JAN-2007, the patient was vaccinated with the first dose of Gardasil. Concomitant therapy included LEXAPRO and ABILIFY. On 31-JAN-2007, the patient's schizophrenia symptoms became worse. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested. Abilify, Lexapro Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Schizophrenia UNK


Page 1149
Days 0
State MI
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a 20 year old female who on 19-FEB-2007 was vaccinated IM with a dose of Gardasil (Lot # 654741/0013U). On 19-FEB-2007, the patient fainted after receiving the Gardasil injection. The patient was known by the provider to be squeamish with injections. After the fainting episode, the patient was observed for a brief period of the time and then was discharged from the physician's office. On 19-FEB2007, the patient recovered. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1150
Days 0
State WI
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Fatigue, Injection site pain, Musculoskeletal pain
Symptom Text: Information has been received from a registered nurse concerning a 12 year old female who on 18-JAN-2007 was vaccinated IM with a first dose of Gardasil. No other vaccinations were administered. On approximately 18-JAN--2007, the patient experienced soreness at injection site, fatigue, musculo-skeletal pain, and joint pain. The following laboratory tests were performed on the patient: complete blood cell (CBC) count; erythrocyte sedimentation rate (sed rate); rheumatoid factor (RF); antinuclear antibodies test (ANA); creatine kinase (CPK); "strep test"; influenza A and B; Lyme disease enzyme-linked immunosorbent assay. All lat test results were reported as normal. The patient was not prescribed any treatment. By 20-FEB-2007, the patient was fully recovered. Additional information is not expected. UNK Other Meds: diagnostic microbiology 01/18?/07 - normal strep test, Lyme disease assay 01/18?/07 - normal, serum creatine kinase 01/18?/07 - normal, serum influenza B Lab Data: virus 01/18?/07 - normal, serum rheumatoid factor 01/18?/07 - normal, serum influenza UNK History: Prex Illness: Prex Vax Illns:


Page 1151
Days 2
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Formication, Limb discomfort, Pain in extremity, Sensory disturbance
Symptom Text: Information has been received from a 24 year old female consumer with a history of prednisone reaction unspecified, and a history of papilloma viral infection, knee surgery 6 weeks for unspecified condition who on 12-FEB-2007 was vaccinated with Gardasil (lot # not reported) injection. Concomitant therapy ORTHO TRI-CYCLEN LO. On 14-FEB-2007, the patient experienced legs (from mid thigh to mid calf) felt creepy-crawling, uncomfortable especially when laying down, they don't feel like my legs after receiving the injection. The patient also reported that her arm was very sore for about 3 days after receiving the injection but that went away. At the time of reporting the creepy-crawling feeling, and limb discomfort persisted. No further information was provided at the time of reporting. Additional information has been requested. ORTHO TRI-CYCLEN LO Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Papilloma viral infection; Knee operation; General symptom Adverse drug reaction


Page 1152
Onset Date Unknown
Days
State VA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a female patient who on an unspecified date was vaccinated IM with Gardasil and experienced a "sore arm" after being vaccinated. Medical attention was sought. The patient was reported as recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1153
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a nurse via a company representative concerning a female (age not reported) with an allergy to bakers yeast and on a gluten free diet who, on an unspecified date, was vaccinated with a second dose of Gardasil and passed out (dates not reported). It was reported that the patient received the first dose with "no problem". At the time of the report, recovery status of the patient was unspecified. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Gluten free diet; Hypersensitivity UNK


Page 1154
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Nasopharyngitis
Symptom Text: Information has been received from a registered nurse concerning a female patient who was vaccinated with a Gardasil. Subsequently the patient developed a cold after the second and third dose. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1155
Onset Date Unknown
Days
State MO
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Drug administered at inappropriate site, Nausea
Symptom Text: Information has been received from a nurse concerning a female patient who was vaccinated with a second dose of Gardasil. The patient was vaccinated in the "glut" per the patient's request. Subsequently the patient felt dizzy and nauseous. It was noted that the patient may have not eaten all day. Subsequently, the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1156
Onset Date Unknown
Days
State PA
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second dose of Gardasil. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1157
Onset Date Unknown
Days
State PA
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first dose or second dose of Gardasil. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1158
Onset Date Unknown
Days
State PA
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician via a company representative, concerning a female patient who was vaccinated with either a first or second dose of Gardasil. Subsequently the patient experienced nausea after vaccination. The patient recovered within a day. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1159
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site bruising, Injection site pain
Symptom Text: Information has been received from a health professional concerning a 25 year old female who was vaccinated with Gardasil. Subsequently the patient experienced injection site pain and the site was bruised. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1160
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning an 18 year old female who was vaccinated with Gardasil. Subsequently, the patient experienced injection site pain. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1161
Days -7
State MO
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy, Gonorrhoea
Symptom Text: Information has been received from a nurse practitioner through the pregnancy registry concerning a 19 year old female with asthma and genital warts and a history of migraines, miscarriage at 4 months of pregnancy and high blood pressure who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (lot # 654741/0013U). Concomitant therapy included ADVAIR and trichloroacetic acid. On 25-JAN-2007 the patient was noted to be pregnant (last menstrual period was on 03-JAN-2007). On 03-FEB-2007 the patient was treated with 500 mg of CIPRO for gonorrhea. At the time of this report, the outcome of the events was unknown. No further details were provided. Additional information has been requested. albuterol, ADVAIR, trichloroacetic acid 80 % Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Migraines; Miscarriage; Blood pressure high Pregnancy NOS (LMP = 1/3/2007), Asthma; Genital wart


Page 1162
Onset Date Unknown
Days
State FL
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a female consumer (age unknown) who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Subsequently, on an unknown date, the patient experienced nausea and dizziness after receiving the second dose of vaccine which was administered with a regular needle. Symptoms subsided after 15-20 minutes. The reporting physician stated that the patient was not affected by the first dose of vaccine which was administered with a safety syringe. The patient sought unspecified medical attention. Subsequently, the patient recovered from nausea and dizziness. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1163
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Nausea, Pyrexia, Syncope, Vomiting
Symptom Text: Information has been received from a physician, via a company representative, concerning a 15 year old female patient who on 19-FEB-2007 was vaccinated with the first dose of Gardasil. On 19-FEB-2007 ("last night"), the patient experienced nausea, began vomiting, fainted for couple of seconds, and developed a fever of 100.7 degrees 12 hours after getting Gardasil. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Body temp 02/19/07 100.7 deg. UNK


Page 1164
Vaers Id: 274316-1 Age Gender F 15.0 VAX Detail: Type UNK HPV4
Days 0
State MD
Prev Doses 0
Symptom Text: Information has been received from a physician, via a company representative, concerning a 15 year old female patient who was vaccinated "during the last couple of weeks" (February 2007), with the first dose of Gardasil. Concomitant suspect therapy included other vaccines (therapy unspecified) that were administered at the visit. The physician reported that the patient "fainted after getting Gardasil and several other vaccines were administered at the same visit. Subsequently, the patient recovered. The patient sought unspecified medical attentions. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1165
Onset Date Unknown
Days
State MO
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated intramuscularly with a first dose of Gardasil. The next day, the patient developed a high temperature of 103 degrees F. Unspecified medical attention was sought. Subsequently, the patient recovered. The physician plans to continue the series of Gardasil. Additional information has been requested. UNK Other Meds: Body temp 103 deg Lab Data: History: Prex Illness: Prex Vax Illns: Papilloma viral infection


Page 1166
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site induration, Injection site pain
Symptom Text: Information has been received from a pharmacist concerning a 12 year old female with no pertinent medical history who in approximately January 2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. Subsequently the patient developed a lump at the injection site. It was reported that the lump at the injection site "recently" became painful. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the lump and pain at the injection site persisted. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1167
Days 1
State AR
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Headache, Influenza like illness, Malaise, Pain
Symptom Text: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and history of drug reactions/allergies unspecified who on 19-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) 0.5 IM. There was no concomitant medication. On 20-FEB2007, the patient developed flu-like symptoms. The patient sought medical attention. The patient reported to the physician that she was experiencing a headache, not feeling well, and all over body pain (but not pain at the injection site). At the time of reporting, the outcome was unspecified. No further information was available at the time of reporting. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK NONE


Page 1168
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Abdominal discomfort, Drug exposure during pregnancy, Pregnancy test positive
Symptom Text: Information has been received from a registered nurse, for the Pregnancy registry for Gardasil, concerning a 19 year old female with no known drug allergies and no pertinent medical history who on 03-NOV-2006 was vaccinated with first dose of Gardasil (lot # not reported) 0.5 ml in the left deltoid. There was no concomitant medication. On 05-JAN-2007, the patient was vaccinated with second dose of Gardasil (lot # not reported). The patient sought medical attention. Her last menstrual period was on 05-DEC-2006. On 29-JAN-2007, the patient's primary physician performed a quantitative beta blood test at the physician's office which was positive for pregnancy. Estimate date of delivery is 11-SEP-2007. On 08-FEB-2007, the patient experienced abdominal discomfort and was sent to the hospital for an ultrasound which was positive for pregnancy. The patient was not hospitalized. At the time of reporting, the patient no longer had abdominal discomfort. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Ultrasound 02/08/2007 positive for Pregnancy, serum beta-human 01/29/07 positive for pregnancy Serum Beta Human 01/29/07 positive for pregnancy.


Page 1169
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site rash
Symptom Text: Information has been received from a physician concerning a female who on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. Subsequently the patient experienced a rash and redness around at the injection site. Subsequently, the patient recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1170
Days 1
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Dysmenorrhoea, Fatigue, Somnolence
Symptom Text: Information has been received from a 21 year old female consumer with pertinent medical history reported as unspecified who on 16-FEB-2007 was vaccinated with the second dose of Gardasil. Concomitant therapy included Yasmin and Amitiza. On 17-FEB-2007, the patient experienced dizziness, menstrual cramping and she felt extremely tired and heavily medicated since she was administered Gardasil on 16-FEB-2007. The patient sought unspecified medical attention. The patient advised that her symptoms were becoming worse and have not improved. Additional information has been requested. Yasmin, Amitiza Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1171
Vaers Id: 274323-1 Age Gender F Unknown VAX Detail: Type UNK HPV4
Onset Date Unknown
Days
State --
Prev Doses 0
Symptom Text: Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil, 0.5ml, IM. The nurse reported that the patient received four other vaccinations that same day but the names of the vaccines were unknown and the Gardasil was given first. Subsequently on an unspecified date, the patient experienced dizziness shortly after administration of the Gardasil. The patient became dizzy, she was laid down, given a drink of juice and was able to get up and leave a few minutes later. Subsequently, the patient recovered from dizziness. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1172
Onset Date Unknown
Days
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Pruritus generalised, Urticaria
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with her first dose of Gardasil and one day later developed hives and itchiness through out her body. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1173
Days 0
State CA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Loss of consciousness, Muscle rigidity, Pallor
Symptom Text: Information has been received from an RN concerning a 21 year old white female student who on 09 Feb 2007 at 11:00 a.m. was vaccinated with her first dose of Gardasil. After giving the injection, the nurse reported that the patient "passed out less then 2 seconds. Patient got extremely almost like a seizure less than 1 second." The patient never lost breathing and came back pale. She was left lying down for 20 minutes, and was discharged well. It was reported that no medical attention was required. No further information is available. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1174
Days 0
State CA
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Hyperhidrosis, Nausea
Symptom Text: Information has been received from a health professional concerning a 19 year old white female waitress who on 12 Jan 2007 was vaccinated IM in left deltoid with her second dose of Gardasil and got dizzy, was sweating and nauseated. Her outcome was unknown. There were no concomitant medications; and no adverse events following prior vaccination. No further information is available. NONE Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1175
Days
State CA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Drug administered at inappropriate site, Flushing, Nausea, Vomiting
Symptom Text: Information has been received from a health professional concerning a 25 year old Hispanic female engineer with no known drug allergies who, on an unspecified date, was vaccinated in the left gluteal muscle with a first dose of Gardasil. There was no concomitant medication. On 26 Oct 2006 the patient became flush, experienced vomiting and nausea. There was no illness at the time of vaccination. It was reported that the patient recovered the same day, 26 Oct 2006. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1176
Days 0
State CA
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Feeling hot, Hyperhidrosis, Nausea, Pain
Symptom Text: Information has been received from a health professional concerning a 17 year old female who on 04-DEC-2006 in the PM was vaccinated with a second dose of Gardasil (lot # 653735/0688F), in the left deltoid. There was no concomitant therapy. On 04-DEC-2006 the patient experienced "pain, hot, sweating, dizzy, nauseated." On 14-SEP-2006 the patient was vaccinated with a first dose of Gardasil (yeast). Additional information has been requested. NONE Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1177
Days 26
State CA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Flushing, Hyperhidrosis, Injection site pain, Nausea, Syncope
Symptom Text: Information has been received from a health professional concerning a 22 year old female with allergy to CECLOR who on 06-DEC-2006 was vaccinated with a second dose of Gardasil (lot #655619/1427F), in the left deltoid. There was no concomitant medication. on 01-JAN-2007 the patient experienced "faint, sweaty, flushed, nauseated and pain (site). Additional information has been requested. NONE Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Allergic reaction to antibiotics.


Page 1178
Vaers Id: 274336-1 (S) Related reports: 274336-2; 274336-3 Age Gender Vaccine Date Onset Date Days F 28-Feb-2007 01-Mar-2007 1 15.0 VAX Detail: Type MNQ HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
State LA
Prev Doses 0 0
ER VISIT, HOSPITALIZED, SERIOUS Chest pain, Cough, Extensor plantar response, Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia, Hypokinesia, Hyporeflexia, Malaise, Pyrexia, Tremor, Vomiting
Symptom Text: The next day after recieving Gardasil and Menactra vaccines pt began to have fever and vomiting as well as headache. On the second day after vaccination she began to experience right hand tremor and left foot numbness. 03/20/07-records received from facility for DOS 3/6-3/9/07. DC DX: Mild Guillain Barre Syndrome status post intravenous immune globulin. Developed subjective fever and feeling ill as well as vomiting. Started having numbness of left foot shaking of right hand and headache. C/O initial chest pain with cough.Suspected Guillain Barre and treatment included immune globulin. Neuro consult plan included IVIG. PE:WNL except for not able to dorsiflex or plantar flex at all as well as limitation although some movement of toes with active motion. Did not elicit ankle jerk at the left. Toes were downgoing on Babinski. Gait slightly unsteady Icar, Advair Other Meds: CBC-wnl, Chest x-ray-wnl, glucose-wnl, urine-wnl, spinal fluid- wnl, MS eval-wnl records received 3/20/07-CSF did not show elevated protein level. Lab Data: CXR:normal EKG normal. none History: Prex Illness: Prex Vax Illns: none


Page 1179
Related reports: 274336-1; 274336-3 Vaccine Date Onset Date Days 28-Feb-2007 05-Mar-2007 5 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
State LA
Prev Doses
ER VISIT, NOT SERIOUS Guillain-Barre syndrome
Symptom Text: Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA03222. The initial reporter to the other manufacturer was a health care professional. This is a verbatim copy of the report from the other manufacturer. "Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot # 654535/0960F. Concomitant suspect therapy included MENACTRA, administered on the same day. Other concomitant therapy included ADVAIR. ON 05-Mar-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain-Barre syndrome was a result of MENACTRA, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested." The information received included a VAERS ID #. This case is being evaluated by CISA (Clinical immunization Safety Assessment network) and has not yet been confirmed. ADVAIR Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma


Page 1180
Related reports: 274336-1; 274336-2 Vaccine Date Onset Date Days 28-Feb-2007 05-Mar-2007 5 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
State LA
Prev Doses
ER VISIT, NOT SERIOUS Guillain-Barre syndrome
Symptom Text: Information has been received from a Nurse Practitioner concerning a 15 year old female patient with asthma who on 28-FEB-2007 was vaccinated with a dose of Gardasil, lot #654535/0960F. Concomitant suspect therapy included Menactra, administered on the same day. Other concomitant therapy included Advair. On 05-MAR-2007 the patient was diagnosed with Guillain-Barre syndrome. Her outcome was not reported. The reporter felt that Guillain Barre syndrome was a result of Menactra, and not Gardasil. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested. Advair Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma UNK


Page 1181
Days 1
State MO
Prev Doses 0
Symptom Text: Patient experienced nausea and vomiting hours after receiving vaccine. Patient also went out to eat after vaccine so it is difficult to determine cause of nausea and vomiting. Nuvaring Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKDA. Scoliosis


Page 1182
Days 1
State MA
Last Edit Date 22-Mar-2007 Other Vaccine HPV4
Prev Doses 1
Site Right arm
Symptom Text: Three week pain in right deltoid after vaccine with Gardasil. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1183
Days 0
Received Date 19-Mar-2007 Lot 0954F U2176FA
State CA
Prev Doses 0 0
Symptom Text: Broke out in hives within 24 hours of receiving HPV and Flu vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1184
Onset Date Unknown
Days
State FL
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Urticaria
Symptom Text: Initial and follow up information has been received from a Licensed Practical nurse and a physician concerning a female patient who was vaccinated with a first dose of Gardasil. She developed hives within 2-3 hours of receiving the injection. Unspecified medical attention was sought. The patient was not recovered. The nurse considered hives to be disabling she was not available for follow up, and when the physician was contacted, he could not provide any information regarding why the nurse considered the event disabling. He had not been able to contact the patient. He had no further information regarding her outcome. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1185
Onset Date Unknown
Days
State NY
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Convulsion, Vaccine positive rechallenge
Symptom Text: Information has been received from a physician concerning an adolescent female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included an unspecified anti malaria medication. Subsequently, on an unspecified date " a few days later" the patient had a seizure. It was reported by the physician that at the time "the patient has a series of tests (NOS) but no diagnosis was found. On another unspecified date the patient received the second dose of Gardasil (lot # not provided) and sixteen days post vaccination, on an unspecified date the patient had seizure. The patient sought unspecified medical attention. The physician reported that it was not known if additional test were completed. The physician reported that the patient had recovered from the seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested. Therapy unspecified Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1186
Days 0
State FR
Prev Doses 0
HOSPITALIZED, SERIOUS Loss of consciousness, Meningism, Muscle spasms, Syncope
Symptom Text: Information has been received from a gynecologist concerning a 17 year old female with a history of emotional lability and probably "stress-related" amenorrhoea who on 01-MAR-2007 was vaccinated with the first dose of Gardasil, IM into the left arm. Concomitant medication was not reported. On 01-MAR2007, about 2 minutes post vaccination, the patient experienced a convulsion syncope with meningism, muscular spasm and unconsciousness. Subsequently after about 3 minutes, the patient recovered from convulsion syncope. The patient was admitted to the hospital. Other business partner numbers included E2007-01514. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Amenorrhea; Affect lability


Page 1187
Onset Date Unknown
Days
State CT
Prev Doses 0
Symptom Text: Pt received vaccine/Gardasil 1/15/07. One week later, developed hives which lasted one week. Pt treated with Benadryl for symptoms relief. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Neurofibromytosis Ortho Tricyclen


Page 1188
Days 7
State SC
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Adverse drug reaction, Dyskinesia, Dystonia, Gaze palsy
Symptom Text: Dystonic reaction treated with IV Benadryl then PO Valium in ER. Second ER visit 2/18/07 treated with Cogentin. Symptoms resolved after 12 days. 03/21/07records received from ER facility for services provided on 3/18 and 3/21/07-DX:Dystonic reaction. HX: involuntary spasms, seen in ER day prior. DX at that time dystonic reaction. treated with benadryl and valium. Had 5 doses of valium, now spasms with eyes rolling. Current medications Lexapro. Allergy: Phenergan (dystonic and psychotic reaction). Neuro exam normal. Spasms observed, eye rolling. DC with cogentin. 2/21/07 seen in ER DX: dystonic medication versus vaccine reaction. Neuro exam normal. No spasm observed. Schedule MRI. 04/11/07-records received from ER for DOS 2/16/07-placed on Lexapro 2 weeks prior to ER visit. C/O erratic jerking moments. Upper body and shoulders. Voluntary control of arms and shoulders, legs and neck intact. HX depression. Additional findings: Facial and left arm muscles contracting spontaneously. DX: Dystonic drug reaction. Discontinue Lexapro. Lexapro Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: MRI 3/2/07 WNL records received 4/11/07-Labs WNL Depression Depression


Page 1189
Days 6
State IL
Prev Doses 0
ER VISIT, NOT SERIOUS Agitation, Anxiety, Chest discomfort, Dizziness, Heart rate increased, Injection site rash, Tremor, Unevaluable event
Symptom Text: None Stated 04/02/07-records received from facility. Developed rash around injection site, pulse 100, felt shaky, tightness in chest and heart felt like it was racing. Feels anxious, agitated, lightheaded. PE:WNL. DX: Anxiety disorder. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CBC, CRP normal


Page 1190
Days 0
State VA
Prev Doses 1
Symptom Text: Syncopal episode after dose #2 of Gardasil vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1191
Days 0
State NV
Type VARCEL HPV4
Prev Doses 1 0
NO CONDITIONS, NOT SERIOUS Dizziness, Nausea, Pallor, Vomiting
Symptom Text: Approximately 5 minutes after administration my child complained of nausea and dizziness, she appeared pale. About 10 min later she vomitted. About 15 min after administration she felt ok. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none none~~NULL~~In Patient|none~~NULL~~In Sibling1|none~~NULL~~In Sibling2


Page 1192
Days 1
Received Date 21-Mar-2007 Lot 1312F 0960F
State LA
Type VARCEL HPV4
Prev Doses 1 1
NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral, Skin warm
Symptom Text: Arm red, warm, swollen 8cmx8cm. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE NONE


Page 1193
Days 2
Received Date 21-Mar-2007 Lot C2557AA U1932AB 0637F
State CA
Prev Doses 0 0 0
Right arm
ER VISIT, NOT SERIOUS Rash papular, Rash pruritic
Symptom Text: Itchy rash on both deltoids started 2 days after immunizations received. Rash is fine and papular. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1194
Days 43
State CO
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Ear pain, Facial palsy, Influenza, Lacrimation increased, Otitis media acute, Swelling face
Symptom Text: Patient received first dose of HPV on 1/26/07, then around 2/24/07 experienced flu symptoms which resolved. Then 3/10/07 experienced right sided facial swelling, right eye tearing, right ear pain. Seen by MD 3/12/07 and diagnosed with Acute Otitis Media and Bell's Palsy. MRI scheduled but not completed yet. Question related Bell's Palsy to vaccination? Levlen OCP Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Condyloma acuminatum


Page 1195
Days 1
Received Date 21-Mar-2007 Lot 0243V
State IL
Prev Doses 0
Symptom Text: Hives on arm (not at injection site) on hands and feet-resolving. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma, Seasonal allergies (dogs and horses per mom) NONE Advair PRN


Page 1196
Days 0
Received Date 21-Mar-2007 Lot C2456AA U1967AA 0186U
State NY
Prev Doses 5 0 0
ER VISIT, NOT SERIOUS Chest discomfort, Neck pain, Pain in extremity
Symptom Text: Severe arm and neck pain, chest tightness, 2 hour post vaccine. No prior history of asthma, abdominal pain. Seen in the ER and discharged with Albuterol. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1197
Days 1
State NY
Prev Doses 0
ER VISIT, NOT SERIOUS Headache, Nausea, Pharyngolaryngeal pain, Pyrexia
Symptom Text: Headache, nausea, fever and continued headache. High fever (temp 105F). Onset of fever 12 hours later same day complained of sore throat. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE White blood cells 13.8 after 86 sc, Negative rapid strep. NONE NONE


Page 1198
Onset Date Unknown
Days
State CA
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Disturbance in attention, Dizziness, Headache
Symptom Text: Pt reported that approximately 24hrs after receiving the vaccinations she had a headache, dizziness. Went home, took shower, slept through the night. The next day she didn't remember much of the previous day. Feels she continues to have trouble absorbing subjects at school. Feels she is gradually getting better. No Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None On menses. No known illness No~~NULL~~In Patient|No~~NULL~~In Sibling1|No~~NULL~~In Sibling2


Page 1199
Days 1
State NH
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Diarrhoea, Headache, Nausea
Symptom Text: Diarrhea, Nausea, headache Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE Vitamin OTC supplements


Page 1200
Days 0
State MD
Prev Doses 1
ER VISIT, NOT SERIOUS Headache, Inappropriate schedule of drug administration, Injection site pain
Symptom Text: Information has been received from a registered nurse concerning a 14 year old female with no medical history and no allergies who on 02-FEB-2007 was vaccinated with a second dose of HPV (lot # 655503/00120), intramuscularly. There was no concomitant medication. On 02-FEB-2007 the patient experienced intermittent headache and soreness at the injection site of the left arm. The patient was examined by the physician on 20-FEB-2007 and was recommended Tylenol. It was noted that the first dose of HPV was received on 27-OCT-2006. At the time of the report, the patient was considered to be not recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1201
Days 0
State MI
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse, via a company representative, concerning a 13 year old female patient who on 11-JAN-2007 was vaccinated with the first dose, 0.5ml, IM of HPV. The nurse reported that the patient had developed vaginal bleeding that had "varied from light to heavy and has been continuous since the date of administration." The nurse reported that the patient had been referred to an OBGYN for further evaluation. At the time of this report, the patient had not recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1202
Days 0
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug administered at inappropriate site, Pain in extremity
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 19 year old female with a history of abnormal papanicolaou smear who on 21DEC-2006 was vaccinated IM in left deltoid with her first dose of HPV, lot # 653736/0689F. Concomitant therapy included Yasmin and Prozac. She experienced severe pain in the arm with the first dose. This reaction was reported at the time of her second vaccination. On 21-FEB-2006 her second dose of HPV, lot # 655617/1447 was administered via gluteus. No symptoms were reported at that time. The patient was reported as recovered on an unspecified date. Additional information has been requested. Yasmin, Prozac Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Papanicolaou smear abnormal


Page 1203
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site swelling, Paraesthesia
Symptom Text: Information has been received from a nurse concerning a 22 year old female with a history of "problems and reactions" to previous vaccinations who was vaccinated with a first dose of HPV. Subsequently, the patient developed swelling around the injection site. The patient was placed on unspecified therapy, and subsequently, recovered. On an unspecified date, the patient was vaccinated with a second dose of HPV. It was reported that the patient experienced a "tingly" sensation in her arm. The patient was treated with unspecified therapy, and subsequently, recovered from the "tingly" sensation. It was reported that the patient had a medical history of similar symptoms after previous vaccinations. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE vaccination adverse event


Page 1204
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse concerning an 18 year old female who, on an unspecified date, was vaccinated intramuscularly with a first dose of HPV. Subsequently, on an unspecified date, the patient developed a rash. The patient did not seek medical attention. Subsequently, on an unspecified date, the patient recovered. No product quality complaint was involved. Additional information is not expected. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1205
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nursing supervisor concerning a female (age not reported) who on an unspecified date was vaccinated with HPV. Subsequently, the patient reported that her "arm felt dead". At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1206
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nursing supervisor concerning a female (age not reported) who on an unspecified date was vaccinated with HPV. Subsequently, the patient reported that her "arm felt dead". At the time of this report, the outcome of the event was unknown. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1207
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pain, Presyncope
Symptom Text: Information has been received from a certified medical assistant (C.M.A) concerning a female patient who was vaccinated with a 0.5 mL dose of HPV, (lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. It was reported that the patient almost passed out from the pain. The C.M.A also reported that approximately 19 other patients experienced pain at the injection site lasting for about a week. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1208
Related reports: 274580-2 Vaccine Date Onset Date 06-Nov-2006 Unknown Manufacturer MERCK & CO. INC.
Days
State TX
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 13 year old female who on 06-NOV-2006 and on 09-JAN-2007 was vaccinated with a first and second dose of HPV. Subsequently the patient experienced irregular menstrual bleeding. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1209
Related reports: 274580-1 Vaccine Date Onset Date 06-Nov-2006 06-Nov-2006 Manufacturer MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR
Days 0
Received Date 07-May-2007 Lot NULL 0954F NULL NULL
State TX
Mfr Report Id 200701447 Route Unknown Unknown Unknown Unknown
Prev Doses 0
Site Unknown Left arm Unknown Unknown
ER VISIT, NOT SERIOUS Menorrhagia, Menorrhagia, Menstruation irregular
Symptom Text: Initial report received on 26 April 2007 from another manufacturer, report number WAES0702USA04012. The initial reporters to this manufacturer was a physician and a registered nurse. Verbatim from report: "Initial and follow-up information has been received from a physician and a registered nurse concerning a 13 year old Hispanic female student with allergic rhinitis, otitis media, asthma and history of cleft palate repair who on the morning of 06-NOV-2006 was vaccinated in the left arm with a dose of Gardasil (yeast) lot #653938/0954F. Concomitant therapy included MENACTRA, hepatitis A Virus vaccine and varicella virus vaccine live. After the patient's first dose of Gardasil (yeast) her menstrual cycle started and lasted about 2-3 weeks. On 09-JAN-2007, she was vaccinated in the right arm with the second dose of GARDASIL (yeast). In late February 2007, the patient's menstrual cycle lasted weeks and she experienced heavy bleeding. In follow-up information received on 22-FEB-2007 the physician reported that patient's mother alleges that since her daughter started GARDASIL (yeast) her periods became irregular and long. Her period in January was 15 days. The mother requested a gynecology consult. The reporter felt that irregular and long menstrual bleeding was an other important medical event. Additional information is not expected." Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: The patient had past medical history of cleft palate with repair, and concurrent conditions of asthma, rhinitis allergic, and otitis media.


Page 1210
Vaers Id: 274581-1 Age Gender F Unknown VAX Detail: Type TDAP HPV4 Seriousness: MedDRA PT
Days 1
State MD
Prev Doses
ER VISIT, NOT SERIOUS Headache, Nausea
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on 20-FEB-2007 was vaccinated with a 0.5 mL first dose of HPV. The patient was concomitantly vaccinated with a dose of Boostrix. On 21-FEB-2007 the patient experienced nausea and a headache. The patient sought unspecified medical attention. On 22-FEB-2007, the headache was clearing and the nausea was gone. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1211
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Fall, Head injury, Loss of consciousness
Symptom Text: Information has been received from a health care professional concerning a 25 year old female with no medical history and no allergies who on 21-FEB-2007 was vaccinated with HPV (lot # 653736/0014U), intramuscularly. There was no concomitant medication. Later that evening she passed out. She hit her head when she fell to the floor. It was reported to be unknown if treatment was required. She called the doctor this morning and was taking the day off from work. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1212
Days 0
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Dyspnoea, Urticaria
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female with no past medical history and no allergies who on 13-FEB-2007 was vaccinated with HPV (0.5 ml) (lot # 653736/0014U), intramuscularly. Concomitant medication included Loestrin. On 13-FEB-2007, "about half hour to hour after vaccination" the patient experienced "shortness of breath" per the patient. About two hours afterwards, the patient was "fine." The nurse mentioned that the patient was anxious about needles and attributed the symptoms to anxiety. On 19-FEB-2007 the patient developed hives on her elbows and knees. On 22FEB-2007 the hives had spread "systemically" to her face, ribs, arms and legs. The patient was ordered on Benadryl by her other physician. The symptoms had not resolved. No further information was available. Additional information has been requested. Loestrin Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1213
Onset Date Unknown
Days
State IN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Urinary tract infection
Symptom Text: Information has been received from a health professional concerning an 18 year old female who on an unspecified date was vaccinated with a first dose of HPV. The patient was due to her second dose of HPV, and she developed a urinary tract infection. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1214
Days 0
State AZ
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Injection site erythema, Injection site pruritus, Injection site swelling, Urticaria
Symptom Text: Information has been received from a physician assistant concerning a 22 year old female with penicillin allergy who on 20-FEB-2007 was vaccinated with a first dose of HPV. On 20-FEB-2007 she developed itching, erythema and swelling at the injection site. On 21-FEB-2007 she developed hives on her abdomen, thighs and chest upon awakening. When she was seen by the physician assistant on 21-FEB-2007 the swelling and redness at the injection site was gone and the patient commented that the hives were less than before. Her prescriber put her on Zyrtec (10 mg) daily for the hives. Unspecified medical attention was sought. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Penicillin allergy


Page 1215
Days 0
State NY
Prev Doses
ER VISIT, NOT SERIOUS Injection site pain, Lymph node pain, Lymphadenopathy, Nausea
Symptom Text: Information has been received from a physician concerning a 25 year old female secretary with on medical history or allergies, who on 20-FEB-2007 was vaccinated IM into the left arm with a 0.5 ml dose of HPV. Concomitant therapy included Depo-Provera. On approximately 20-FEB-2007, the patient experienced soreness at injection site. On 21-FEB-2007 for that day only the patient experienced nausea. On the morning of 22-FEB-2007 the patient noticed what looks similar to lymph nodes that are enlarged, tender, and swollen by the wrist of the arm in which the vaccine was administered. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report the patient recovered from all events but had not recovered from soreness at the injection site. No product quality complaint was involved. Additional information has been requested. Depo-Provera Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1216
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 16 year old female with penicillin allergy who on 12-FEB-2007 was vaccinated with a dose of HPV (lot #653736/0014U). There was no concomitant medication. On 12-FEB-2007 the patient developed large hives on her arms, trunk and face. Medical attention was sought and the patient was treated with Benadryl 100 mg. There were no laboratory or diagnostic tests performed. On 13-FEB-2007, the patient recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE Penicillin allergy


Page 1217
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician's office concerning a 16 year old female who was vaccinated with a dose of HPV. Subsequently, the patient fainted. The patient did not seek medical attention. The patient's outcome was unknown. Additional information is not expected. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1218
Days 0
State CO
Prev Doses 1
Site Unknown
Symptom Text: information has been received from a consumer concerning her 19 year old daughter who on 22-FEB-2007 was vaccinated with her second dose of HPV. Concomitant therapy included unspecified birth control. On 22-FEB-2007 the patient experienced "a lot of pain and was in tears" after receiving HPV. Unspecified medical attention was required. It was also reported that the patient experienced "a little pain" after the first dose of HPV was administered. At the time of the report, the patient's pain persisted. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1219
Onset Date Unknown
Days
State MI
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning her daughter who was vaccinated with a dose of HPV during her Christmas holiday break from college. After the vaccination, the patient walked to the reception desk and fainted. The patient awoke by herself. Unspecified medical attention was sought. It was reported that the patient was embarrassed, then walked out to the car with her parents. Subsequently, the patient recovered. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1220
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a dose of HPV. Subsequently, on an unspecified date, the patient passed out after receiving the vaccine. The nurse reported that the patient had not eaten. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1221
Days 2
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Chest pain, Dyspnoea
Symptom Text: Information has been received from a registered nurse concerning a female with asthma who on 17-NOV-2006 was vaccinated with the first dose of Gardasil. On 19-NOV-2006, the patient experienced shortness of breath and chest pain. The patient recieved unspecified treatment at the clinic where she was employed. It was reported that the patient attended work the following day, although, had recurrence of shortness of breath. The patient's outcome was unknown. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma UNK


Page 1222
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, Pain in extremity, Paraesthesia, Skin burning sensation, Vaccine positive rechallenge
Symptom Text: Information has been received from a female nurse practitioner consumer through the pregnancy registry who on unspecified dates was vaccinated with the first and second doses of Gardasil (0.5 ml). Subsequently the patient reported that she had recently became pregnant. The patient also reported that she experiences burning, pain, and nerve tingling in her arm "soon after" receiving the second dose of Gardasil. The patient reported that she had a similar experience to a lesser degree following the first vaccination with Gardasil. It was though that the pregnancy occurred after the above events. Unspecified medical attention was sought. The patient subsequently recovered from the burning, pain, and nerve tingling in her arm "a short time after each injection." Additional information has been requested. UNK Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown)


Page 1223
Days 0
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Headache, Inappropriate schedule of drug administration, Lip swelling, Neck pain, Pharyngolaryngeal pain
Symptom Text: Information has been received from a consumer concerning her 12 year old daughter with a history of surgery for birth defects and allergic to erythromycin who on 15-JAN-2007 and 16-FEB-2007 was vaccinated with a first and second dose of Gardasil, respectively. There was no concomitant medication. On 22-FEB2007 'last night", the consumer's daughter experienced headache, sore throat, neck pain and her lips were swollen. No medical attention was sought. No laboratory studies were performed. At the time of this report, the consumer's daughter had not recovered. It was also reported that she tolerated her first of the vaccine with any events. The consumer plans on having her daughter receive the third dose of the vaccine. No product quality complaint was involved. Additional information is not expected. NONE Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: Birth defects; Surgery Allergic reaction to antibiotics


Page 1224
Days 17
Received Date 16-Mar-2007 Lot U1974AB 0960F
State PA
Prev Doses
ER VISIT, NOT SERIOUS Abdominal pain upper, Diarrhoea, Facial palsy, Facial palsy, Herpes zoster oticus, Herpes zoster oticus
Symptom Text: Information has been received from a registered nurse concerning a 11 year old female who was vaccinated with a dose of Gardasil. Concomitant therapy administered at the same time at a different anatomical site included a dose of MENACTRA. Illness at the time of vaccination included herpes simplex on the lip. On 09-JAN-2007, the patient was seen in the office and was diagnosed with herpes zoster otitis which progressed to a diagnosis of Bell's palsy and Rasmsay-Hunt Syndrome on 15-JAN-2007. At time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 03/28/07-records received for DOS 1/16/07 DX:Bell's Palsy. Ramsay Hunt Syndrome. PH:1/9/07-Seen by PMD to treat shingles in right ear with acyclovir. TX stopped on 1/16/07 due to bells palsy. Right side facial droop difficulty eating. C/O headache thoughout with shingles. 1/16/07-stomach cramps, diarrhea. Symptoms resolved 2/8/07. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Herpes on lip


Page 1225
Days 13
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Influenza like illness, Pyrexia
Symptom Text: Information has been received from a consumer concerning her daughter, an 18 year old female patient who on 09-FEB-2007 was vaccinated with the first dose of Gardasil. The caller reported that on 10-FEB-2007, her daughter "had a TB test administered. "On 22-FEB-2007 the patient experienced fever and flulike symptoms. The patient sought unspecified medical attention. Additional information is not expected. MANTOUX SKIN TEST Other Meds: NONE Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1226
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Head injury, Syncope
Symptom Text: Information has been received from a registered nurse concerning a 24 year old female patient who on 20-FEB-2007 was vaccinated with an 0.5 ml dose, IM, of HPV. there was no concomitant medication. On 20-FEB-2007 the nurse reported that the patient "fainted while walking to the waiting room," although the nurse further clarified that the patient "did not lose consciousness, but she hit her head." The patient recovered, and was released to her parents. The patient sought unspecified medical attention. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1227
Days 0
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Concussion, Head injury, Syncope
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female with no pertinent medical history and no drug reactions or allergies who on 29-JAN-2007 was vaccinated intramuscularly with a 0.5 mL dose of HPV (Lot unspecified by reporter). There was no concomitant medication. On 29JAN-2007 the patient fainted while walking to the waiting room. The patient hit her head on the floor and suffered a concussion. The patient was rushed to an emergency room in an ambulance. She was release later that day. At the time of the report, the patient had recovered. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1228
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a Certified Medical assistant (C.M.A) concerning an 18 year old female patient who was vaccinated with her first dose of HPV. The patient called the office back within 24 hours reporting a large rash on her back. Concomitant therapy included albuterol. The patient's outcome was unknown. Additional information has been requested. albuterol Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1229
Onset Date Unknown
Days
State MO
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Body temperature increased
Symptom Text: Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated intramuscularly with a first dose of HPV. The next day, the patient developed a high temperature if 103 degrees F. Unspecified medical attention was sought. Subsequently, the patient recovered. The physician plans to continue the series of HPV. Additional information has been requested. UNK Other Meds: body temp, 103 degr Lab Data: History: Prex Illness: Prex Vax Illns: Ppailloma viral infection


Page 1230
Days 0
State --
Prev Doses 0
Site Unknown
PERMANENT DISABILITY, SERIOUS Abdominal pain, Ovarian cyst, Ovarian cyst ruptured, Vomiting
Symptom Text: Information has been received from an office receptionist concerning a 12 year old female who in January 2007 was vaccinated with the first dose of Gardasil. Concomitant mediation was not reported. In January 2007, the developed an ovarian cyst that ruptured 10 days after receiving the first dose of Gardasil. Initially, the patient started vomiting for a few days and then there was significant abdominal pain. The patient was examined and diagnosed with ruptured ovarian cyst. The patient's ovarian cyst and ruptured ovarian cyst persisted and were considered to be disabling. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ultrasound 01/??/07 - results not reported UNK


Page 1231
Days 0
State MA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Dizziness
Symptom Text: Patient had complaints of lightheadedness/dizziness approx. 5-10 minutes after injection. Lasted for approx. 5 minutes. Patient was seated, cold cloth applied to neck and wrists, given water to drink. s/s resolved with intervention and seating. Patient with no other complaints. Orthotricyclen-lo Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: N/A no allergies, dysmenorrhea, H. Pylori 4-2006, mono 4-2006, none T 98.1, patient was seen on 03-14-2007 for viral pharyngitis


Page 1232
Days 0
Received Date 23-Mar-2007 Lot C2457AA 1426F
State WI
Prev Doses 0 0
ER VISIT, NOT SERIOUS Blood pressure, Chills, Confusional state, Dizziness, Muscle contracture, Oxygen supplementation, Pallor, Paraesthesia, Paraesthesia, Paraesthesia oral, Posture abnormal, Sensation of heaviness, Unresponsive to stimuli
Symptom Text: Adacel given first, appeared fine. HPV then given and within a minute or two, client's chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64). Then became aroused, although very confused and unsure where she was. Called out for her mom and asked where she was and said she felt dizzy. Client then assisted off chair to floor. Became extremely pale, c/o lips tingling, B/P 130/64 at 1800. While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills. At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805). Given oxygen per EMS. Client transported to ER. Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None noted on vaccine history form completed by mother before immunizations given No NONE per parent~~NULL~~In Patient|NONE per parent~~NULL~~In Sibling1|NONE per parent~~NULL~~In Sibling2


Page 1233
Days 1
State MA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Headache, Nausea, Pyrexia
Symptom Text: Patient called office with complaints of feeling feverish,dizziness,headache, and nausea. Onset 24-28 hours after injection. Symptoms lasted approx 24 hours. Patient used Tylenol with good effect. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none Allergies:PCN-rash, Peanuts-hives none


Page 1234
Days 5
State MA
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Herpes zoster, Tremor, Vomiting
Symptom Text: Patient states awoke during night with trembling, dizziness, vomiting x's 1 approx 5 days after injection#1. Pt with IDDM, BS elevated at that time. Episode lasted approx two hours. Also with similar complaints after Injection #2, will report as separate event. Of note, pt diagnosed with Shingles on 3-5-07. Seasonale(OCP), Novalog 1unit/20gm carbs, Lantus 9units @HS, Zoloft 100mg Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none IDDM onset 6-2005, Celiac Sprue 7-2006 Viral pharyngitis and ear pain at time of injection. T 98.7


Page 1235
Days 4
State MA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Headache, Tremor, Vomiting
Symptom Text: Patient awoke during night with shakiness, headache, and vomited x's one 3 days after vaccination with second dose of Gardasil. Episode lasted approx one hour. Pt has IDDM, BS normal at that time. Same occurred after dose #1 which was reported as separate event. Seasonal (OCP),Novalog 1unit/20 gm carbs, Lantus 9 units @ HS, Zoloft 100mg. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none IDDM onset 6-2005, Celiac Disease onset 7-06 Had been diag with Shingles on 3-5-07. Felt well at time of vaccination. T 98.0 Same symptoms~Human Papillomavirus Recombinant Vaccine, Quadrivalent (Gardasil)~1~19~In Patient


Page 1236
Days 0
State NC
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Pyrexia
Symptom Text: She ran a fever of 101 F for 24 hours beginning beginning 4-6 hours after the administration of the second dose of the vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1237
Onset Date Unknown
Days
State FL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Drug exposure during pregnancy
Symptom Text: We are reporting that the patient became pregnant after receiving 1st dose of Gardasil. her last menstrual period was 1/17/07. She reported pregnancy to us on 3/1/07. Her EDC is 10/24/07. She received Gardasil on 1/16/07. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to Amoxicillin NONE


Page 1238
Days 0
State CA
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Hyperhidrosis, Nausea, Syncope
Symptom Text: Fainting, sweating, nausea Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1239
Days 12
State MI
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Abasia, Cyanosis, Joint swelling, Pharyngolaryngeal pain, Pyrexia, Rash, Serum sickness
Symptom Text: fever, rash, swollen joints (ankles, elbows, shoulders), can't walk, sore throat, toes blue. Probable Serum sickness Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1240
Days 1
State FL
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Drug hypersensitivity, Erythema, Pruritus, Swelling, Swelling face
Symptom Text: Patient called 3/15/07. Patient states the morning after she received her 2nd dose of Gardasil, when she woke up her face and neck was red and cheeks were puffy and also itchy. Patient did state she was in the sun x 45 minutes after she left our office- was using a new sunblock x 4days. Patient states swelling and redness was gone by the next day. No treatment. YAZ Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Ibuprofen, Seasonal allergies NONE


Page 1241
Days 0
Received Date 23-Mar-2007 Lot 0088V
State MD
Prev Doses 0
ER VISIT, NOT SERIOUS Arthralgia, Hypoaesthesia, Mobility decreased, Pain in extremity
Symptom Text: Right hand soreness and numbness, afebrile, pain with movement limits use of hand, no weakness. Right knee aching, worse with waking. BP 139/93, pulse 97 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Lisinopril celera Normal blood work, normal EKG NONE NONE


Page 1242
Days 0
Received Date 23-Mar-2007 Lot C2638AA 0960F
State PA
Prev Doses 0 0
Symptom Text: Both arm and elbow itchy. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 1243
Days 6
State CO
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Food allergy, Urticaria
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female patient with allergies to cast and scallops who on 21-FEB-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included NYQUIL. 20 hours later, the patient developed hives. Unspecified medical attention was sought. The patient's hives persisted. The reporter indicated the patient had hives from the vaccine. Additional information has been requested. NYQUIL Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to cats; Food allergy


Page 1244
Days 0
State OK
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Influenza like illness, Pyrexia, Rash
Symptom Text: Information has been received from a licensed practical nurse concerning a 24 year old female with no pertinent medical history and no history of drug reactions/allergies who on 12-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) 0.5 ml IM. Concomitant therapy included YASMIN and ULTRAM. On 12-FEB-2007, the patient developed a rash on her chest, low grade fever and she felt like she had the flu after receiving the first immunization with Gardasil. Unspecified medical attention was sought. On 13-FEB-2007, the patient recovered. No other information was available at the tiem of reporting. Additional information has been requested. YASMIN, ULTRAM Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Temperature measurement 2/12/07 low grade fever None


Page 1245
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 17 year old female with a cold at the time of the vaccination and unspecified if history of drug reaction /allergies who on 22-FEB-2007 was vaccinated with first dose of Gardasil (lot # not reported) IM. Concomitant therapy included NYQUIL for the cold. On approximately 22-FEB-2007, within 12 to 18 hours of being vaccinated, the patient experienced hives which started on his hips and chest and then spread to her neck and face. Medical attention was sought. The outcome of the hives was not reported. No further information was available at the time of reporting. Additional information has been requested. NYQUIL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Cold Cold


Page 1246
Days 13
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Pain in extremity, Syncope
Symptom Text: Information has been received from a mother concerning her 18 year old daughter who on 14-DEC-2006 was vaccinated with Gardasil (lot # not reported) IM. Concomitant therapy included "TENUS therapy unspecified and hepatitis A virus vaccine (unspecified)" date not provided. The mother reported that her daughter fainted and also experienced pain in her arm after receiving Gardasil. The onset date was reported as 24-Dec-2006. At the time of reporting, the patient had recovered. Additional information has been requested. (therapy unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1247
Days 0
State NY
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date in January 2007, was vaccinated with Gardasil (lot # not provided). That same day the patient experienced dizziness after the vaccination. At the time of this report the patient had not recovered from the dizziness. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1248
Days 0
State IL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Body temperature increased, Chest pain, Nausea
Symptom Text: Information has been received from a nurse a the daughter of a female patient (demographics not provided) who on 06-SEP-2006 was vaccinated with the first dose of Gardasil (Lot # not provided). The mother reported to the nurse that on 06-SEP-2006 after receiving the vaccination her daughter developed an elevated temperature (actual measurement not provided), nausea and chest pain. The mother reported to the nurse that she gave her daughter Benadryl (dose not provided). It was reported that the nausea, elevated temperature and chest pain resolved "in about three days". Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1249
Days 1
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Feeling hot, Headache, Inappropriate schedule of drug administration, Motion sickness, Nausea, Pyrexia
Symptom Text: Information has been received from a nurse concerning a 27 year old female who on 12-FEB-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # not provided). Subsequently, on 13-FEB-2007 the patient reported that her "face felt hot", she had a fever, nausea and headache. On 23-FEB2007 the patient reported that she had an additional symptom similar to motion sickness. The patient sought unspecified medical attention. At the time of this report the patient has not recovered from the events. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1250
Days 8
Status Date 02-Apr-2007
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Axillary mass, Axillary pain
Symptom Text: Information has been received from a registered nurse concerning a 17 year old female who on 14 Feb 2007 was vaccinated IM in the left deltoid with a 0.5mL dose of Gardasil vaccine. There was no concomitant medication. On 22 Feb 2007 the patient "developed a painful lump underneath the arm pit of the same injection arm". The nurse reported that the patient was told to follow up with the physician as soon as possible. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1251
Days -365
Received Date 16-Mar-2007 Lot NULL NULL NULL
State KY
Mfr Report Id WAES0702USA04332 Route Unknown Intramuscular Unknown
Type VARCEL HPV4 HEPA
Prev Doses 1
ER VISIT, NOT SERIOUS Erythema, Oedema peripheral
Symptom Text: Information has been received from a health professional ("nurse"), via a company representative concerning a 15 year old female who on approximately 14 Feb 2007 ("sometime last week") was vaccinated IM with a second dose of Gardasil vaccine (yeast) (the patient's first vaccination date was not reported). Concomitant suspect vaccinations included a dose of Varicella and hepatitis A vaccine (inactive). On approximately 14 Feb 2006 ("sometime last week"), the instant after getting the vaccinations, the patient developed a "swallowed" red arm 8-9cm long and 6 cm wide. At the time of the report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: immunization


Page 1252
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Loss of consciousness, Paraesthesia, Paraesthesia
Symptom Text: Information has been received from a registered nurse concerning a female patient who on 23 Feb 2007 was vaccinated with the first dose of Gardasil. On 23 Feb 2007, after the vaccination, the patient passed out and experienced a tingling sensation in her extremities. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1253
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Loss of consciousness, Malaise
Symptom Text: Information has been received from a registered nurse concerning a 13 year old female who on 21 Feb 2007 was vaccinated with 0.5ml dose of Gardasil. Concomitant therapy included Adacel. Subsequently the patient "felt sick" and passed out. It was reported that the patient was at home when she passed out but it was unknown how long after she received the vaccination. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1254
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from an office manager concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of Gardasil, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced a rash over body and legs that caused severe itching after Gardasil vaccine was administered. On an unspecified date, the patient sought unspecified medical attention. The patient's rash over body and legs that caused severe itching persisted. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1255
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, on an unspecified date, the patient passed out after receiving the vaccine. The nurse reported that the patient had not eaten. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. Unknown Other Meds: unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1256
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a consumer concerning her daughter, a female patient who was vaccinated with the first dose of Gardasil. Subsequently the patient "broke out in hives after initial dose." It is unknown if the patient recovered. The patient sought unspecified medical attention. Additional information is not expected. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1257
Days 19
State MP
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Photosensitivity reaction, Rash pruritic, Uveitis
Symptom Text: Information has been received from a registered nurse concerning her daughter, a 17 year old female patient, with a history of a "hive like reaction" after receiving a dose of MMR (vaccine) when she was 1 year old," who on 03 Feb 2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. Following the vaccination, on 22 Feb 2007, the nurse reported that her daughter developed uveitis with photosensitivity and an itchy rash to her legs, arms and trunk. The nurse confirmed that the uveitis was treated with prednisone eye drops, and the condition "improved." The nurse stated that the rash on her daughter's legs, arms and trunk had not resolved. Additional information has been requested. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE rash urticaria-like, drug hypersensitivity


Page 1258
Days 730
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure normal, Diarrhoea, Dizziness, Fall, Loss of consciousness
Symptom Text: Information has been received from a registered nurse concerning a 21 year old female patient with autoimmune hepatitis, who on 15 Feb 2005 was vaccinated with a dose, 0.5ml, IM, of Gardasil. Concomitant suspect therapy included Adacel, and other concomitant medication included birth control pills, prednisone, vitamins (unspecified) and calcium (unspecified). The nurse reported that on 15 Feb 2007, "20 hours later," the patient "felt lightheaded and passed out. She came to and when she got up she passed out and fell to the floor." The nurse further stated that "both episodes were very brief." On approximately 16 Feb 2007 ("later") the patient "had one episode of diarrhea." On the morning of 16 Feb 2007, the nurse stated that the patient was seen by the doctor and "blood pressure was normal and injection site looked fine. No treatment required." At the time of this report, the patient had recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1259
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician who reported that her daughter was vaccinated with her second dose of HPV and experienced pain during the injection. The patient stated there was no pain when she received the first dose of HPV. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. No further information is available. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1260
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Face injury, Haemorrhage, Syncope
Symptom Text: Information has been received from a nurse practitioner concerning a female (age not reported) with a history of "becomes sqeemish after being administered shots" who on approximately 01-JAN-2007 (about 8 weeks ago) was vaccinated with the first dose of HPV. Concomitant medication was not reported. On approximately 01-JAN-2007 (about 8 weeks ago), the patient fainted in the elevator after being administered the HPV and she hit her nose which started to bleed. The patient sought unspecified medical attention and was given an x-ray which showed that her nose was not broken. The patient was recovering from the events. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: x-ray, 01/01/07, nose not broken Post procedural nausea


Page 1261
Onset Date Unknown
Days
State NY
Type VARCEL HPV4
Prev Doses 1
ER VISIT, NOT SERIOUS Erythema, Rash generalised, Rash maculo-papular
Symptom Text: Information has been received from a physician concerning a 19 year old female who on 14-NOV-2007 and 16-JAN-2007 was vaccinated intramuscularly with a 0.5 mL dose of HPV. On 16-JAN-2007, concomitant therapy included a second dose of varicella. Subsequently, on an unspecified date, the patient developed a generalized body rash (20-30 lesions) which were macular papules/erythema and were mainly on the upper extremities and some on the abdomen. There were none on the hands or feet or in the mouth. The patient did not have a temperature or lymph swelling. The papules/erythema were non-painful and not itchy. The physician stated that it did not present like chicken-pox. Routine blood work was performed (results not provided). At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory, routine blood work Unknown


Page 1262
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been requested from a registered nurse concerning a female patient between the ages of 11 to 13 who within the last 3 months was vaccinated intramuscularly with a 0.5mL dose of HPV. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1263
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female patient between the ages of 11 to 13 who within the last 3 months was vaccinated intramuscularly with a 0.5 mL dose of HPV. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1264
Days 50
State VA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Menorrhagia, Menstruation irregular, Vaginal odour
Symptom Text: Information has been received from a consumer concerning her daughter, an 11 year old female patient who in approximately December 2006 ("about two months ago"), was vaccinated with the first dose of HPV (yeast). There was no concomitant medication. On approximately 20-JAN-2007 ("next menses"), the mother reported her daughter's "menses was longer than usual," and lasted for six days. The mother reported her daughter's menses usually "last three days." She also reported the menses was "very heavy and had a foul odor." The patient did not seek medical attention. It was unknown if the patient recovered. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1265
Days 21
State CT
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Hyperaesthesia, Injection site pain, Muscle disorder
Symptom Text: Information has been received from a Health care Professional concerning a 26 year old female police officer with muscle sensitivity who on 02-NOV-2006 was vaccinated in left deltoid with a 2nd dose of HPV, lot # 653736/0868F. On 23-NOV-2006 the patient was sore at muscle site on an off for 3 days, and she still noticed sensitivity three weeks post injection. No medical attention was sought. The patient reported as recovered. No further information is available. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Myalgia


Page 1266
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician assistant (PA) concerning a female patient who in "early" December 2006, was vaccinated with the first dose of HPV (yeast). The PA reported that the patient "did not have any symptoms except" what the PA stated was "normal pain at the moment of injection." The patient sought unspecified medical attention. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1267
Days 1
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Urticaria, Vomiting
Symptom Text: Information has been received from a Physician Assistant (P.A.) concerning a 20 year old female with a history of hives once a year who on 21-FEB-2007 was vaccinated IM with a dose of HPV, lot # 655618/0786U. On 22-FEB-2007 the patient developed hives over her entire body and vomiting. The reporter also noted that in addition to her history of hives, members of her family had a stomach virus with vomiting so it was unclear if her symptoms were from the vaccine. Diphenhydramine hydrochloride (BENADRYL) was ordered for the hives. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Hives


Page 1268
Days 1
State NM
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration, Injection site pain
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female with a cardiac murmur who on 28-NOV-2006 was vaccinated IM with her first dose of HPV, lot #654540/0800F. On 29-FEB-06 the patient experienced minor soreness around the injection site. The patient did not return for her 2nd dose until 27-FEB-2007. The patient recovered. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Cardiac murmur


Page 1269
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Crying, Pain, Pain in extremity
Symptom Text: Information has been received from a nurse practitioner and a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil. Subsequently, the patient ended up crying and reported she had pain, when the vaccine was being administered, either left or right arm and had some pain afterwards. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested. unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: unknown unknown


Page 1270
Onset Date Unknown
Days
State NY
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Crying, Pain
Symptom Text: Information has been received from a nurse practitioner and a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil. Subsequently, the patient ended up crying and reported she had pain, when the vaccine was being administered, either the left or right arm and had some pain afterwards. Unspecified medical attention was sought. At the time of this report the patient had recovered from the events (date unknown). Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1271
Onset Date Unknown
Days
State IL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Fungal infection
Symptom Text: Information has been received from a consumer concerning her 11 year old daughter with asthma and sulfonamide allergy and a history of yeast infections who in approximately November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included ALLEGRA, SINGULAIR, ADVAIR, NASONEX, PROZAC. Subsequently, it was reported that the patient's "yeast infection has become more severe." Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested. ALLEGRA, SINGULAIR, ADVAIR, NASONEX, PROZAC Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Yeast infection Asthma, Sulfonamide allergy


Page 1272
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Complex regional pain syndrome
Symptom Text: Initial and follow-up information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (lot #655617/1447F). Subsequently, 2 days after vaccination, the patient experienced "RSD reaction" that started in her upper extremities and then moved to her lower extremities. The patient is undergoing a neurology work-up. At the time of the follow-up report, the patient had not recovered. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1273
Onset Date Unknown
Days
State NJ
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Adverse event, Neck pain, Pain in extremity
Symptom Text: Information has been received from a registered nurse concerning a 14 year old female with asthma who on 26-OCT-2006 was vaccinated with the first 0.5 ml dose of Gardasil, (Lot # 653735/0688F). On 12-28-06, the patient was vaccinated with the second 0.5 ml dose of Gardasil (Lot # "0916F"). The nurse reported that the patient had adverse experiences after vaccination. The patient experienced neck pain. Also, the patient's arm "had hurt all the way down, off and on". At the time of the report the patient's symptoms began after the first and second dose of Gardasil. At the time of the report, the symptoms had not resolved. The nurse also mentioned that the patient participated in gymnastics. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma None


Page 1274
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse (LPN) concerning an approximately 13 year old ("about 13 years of age") female patient who was vaccinated with a dose of Gardasil. Subsequently the nurse reported that the patient's period (menstrual cycle) is "a little over a week late." At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1275
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Anaemia, Dizziness, Loss of consciousness, Menorrhagia
Symptom Text: Information has been received from a nurse practitioner (NP) concerning a 14 year old female patient with an allergy to wool, who on 27-DEC-2006 was vaccinated with a dose of Gardasil (Lot # 653735/0688F). Concomitant therapy included DEPO-PROVERA, also administered on 27-DEC-2006. In approximately December 2006 ("since vaccination"), the patient "experienced anemia, dizziness, and heavy menstrual cycles." The NP also stated that the patient reported she "felt like she was going to pass out, but did not report passing out." The NP added that the "patient is receiving iron to treat the anemia." Diagnostic labs were performed (date not specified) including a complete blood count (CBC) (result not provided), hemoglobin 10.8 (unit not provided), and hematocrit 31.7 (unit not provided). At the time of this report, the patient had not recovered. Additional information has been requested. DEPO-PROVERA Other Meds: hemoglobin 01?/??/07 10.8, complete blood cell 01?/??/07, hematocrit 01?/??/07 31.7 Lab Data: History: Prex Illness: Prex Vax Illns: Allergy to wool


Page 1276
Days 2
State FL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Nausea, Pain in extremity, Pyrexia, Swelling
Symptom Text: Information has been received from a physician, via a company representative concerning a female patient who on approximately 21 Feb 2007 ("last week") was vaccinated with the first dose of Gardasil. The physician reported that the "patient came back a few days after first dose of (Gardasil) and complained arm pain, swelling, fever and nausea" (approximately 23 Feb 2007). The physician confirmed that the patient had recovered "after a few days" (approximately 26 Feb 2007). The patient sought unspecified medical attention. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1277
Onset Date Unknown
Days
State IL
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female patient with depression who on 28-DEC-2006 was vaccinated IM with her first dose of Gardasil, lot #654389/0961F. Concomitant therapy included CONCERTA and DEPO-PROVERA. The patient developed a generalized "hive like rash" after her first dose of Gardasil. The nurse reported that the rash "comes and goes". Unspecified medical attention was sought. The patient had not recovered as of the report date. Additional information has been requested. DEPO-PROVERA, CONCERTA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Depression Unknown


Page 1278
Days 2
State MN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Erythema nodosum, Pain, Skin lesion
Symptom Text: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 year old female patient who on 26-FEB-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included ORTHO-CYCLEN. On 28-FEB-2007 the patient developed red, painful lesions on her feet. The physician characterized the above lesions as similar to erythema nodosum. The physician ordered erythrocyte sedimentation rate (ESR) measurement, the result of which had not yet been obtained. The patient's outcome was unknown. Additional information has been requested. ORTHO-CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: erythrocyte - result has not yet been obtained Unknown


Page 1279
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Agitation, Dizziness, Nausea
Symptom Text: Information has been received from a health professional concerning a 17 year old female patient with history of acne and dyspepsia who on 28-FEB-2007 was vaccinated IM with her first dose of Gardasil lot #655503/0012U. Concomitant therapy included PREVACID, RETIN-A and CLEOCIN. The patient reported that she felt dizzy, nauseated and agitated starting 30 minutes after receiving the infection. The physician advised the patient to rest, monitor symptoms and call the office if no improvement. The patient's outcome was unknown. Additional information has been requested. CLEOCIN, PREVACID, RETIN-A Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Acne; Dyspepsia Unknown


Page 1280
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Blister, Herpes zoster, Pain, Rash
Symptom Text: Information has been received from the mother of a female consumer who in January 2007, was vaccinated with a dose of Gardasil. The patient experienced pain, a rash and then full blown blisters. She went to her physician and was diagnosed as shingles. The patient's outcome was unknown. No further information is available. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1281
Days 0
State NY
Prev Doses 0
ER VISIT, NOT SERIOUS Injection site erythema, Injection site pruritus, Injection site rash
Symptom Text: Information has been received from a registered nurse concerning a female with high grade cervical dysplasia who on 23-FEB-2007 was vaccinated intramuscularly, into the left deltoid, with a first 0.5 ml dose of Gardasil (lot #653736/0014U). There was no concomitant medication. A few days after the vaccination, the patient developed a red, itchy, bumpy rash at the injection site. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Cervical dysplasia None


Page 1282
Onset Date Unknown
Days
State CA
Prev Doses 0
ER VISIT, NOT SERIOUS Abdominal pain, Back pain, Chills, Dizziness, Injection site pain, Nausea, Pruritus, Pyrexia
Symptom Text: Information has been received from a nurse practitioner concerning a 26 year old female with no pertinent medical history who on 18-DEC-2006 was vaccinated intramuscularly, into the left deltoid with a first 0.5 ml dose of Gardasil (lot # "0604F"). Concomitant therapy included vitamins (unspecified). Subsequently the patient experienced soreness at the injection site, sacral back pain, mild low abdominal cramping, nausea, generalized itchiness, mild dizziness and "felt feverish with chills." Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient recovered in 1 week without treatment. Additional information has been requested. vitamins (unspecified0 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1283
Days 0
State NJ
Mfr Report Id 1WAES0703USA0021 Route Unknown
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Headache
Symptom Text: Information has been received from a health professional concerning her 16 year old daughter who on 21-FEB-2007 was vaccinated with a first dose of Gardasil. On 21-FEB-2007 the patient experienced a bad headache. She was given two ADVIL and her headache went away the following day. On 21-FEB2007, the patient recovered. No product quality complaint was involved. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1284
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received a licensed practical nurse (LPN) concerning an approximately 13 year old ('about 13 years of age") female patient who was vaccinated with a dose of Gardasil. Subsequently the nurse reported that the patient's period (menstrual cycle) is "a little over a week late." At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1285
Onset Date Unknown
Days
State MI
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced dizziness and sought unspecified medical attention. No further information was provided. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1286
Onset Date Unknown
Days
State MI
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced dizziness and sought unspecified medical attention. No further information was provided. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1287
Onset Date Unknown
Days
State CA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Musculoskeletal stiffness, Neck pain
Symptom Text: Information has been received from a physician via a company representative concerning a female in her early 20's who, on an unspecified date, was vaccinated with a dose of Gardasil. It was reported that the patient experienced neck pain and stiffness after the injection. The pain was reported to have lasted much longer than expected. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1288
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician's assistant concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot # not reported). Concomitant therapy was unspecified. The patient sought unspecified medical attention. Subsequently, the patient experienced a rash. The specifics of the rash were not reported. The outcome of the rash was not reported. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1289
Days 0
State --
Prev Doses 0 0
ER VISIT, NOT SERIOUS Injected limb mobility decreased, Pain in extremity, Pyrexia
Symptom Text: Information has been received from a physician concerning an 18 year old female student (weight 131#, height 66.5") who on 14-DEC-2006 at 2 pm was vaccinated with the first dose of Gardasil (lot #654540/1162F), IM in the right arm. Concomitant therapy included Menactra (lot #41974ab), IM in the left arm. On approximately 14-DEC-2006, the patient developed fever T > 100 within 24 hours of vaccination, her arm was very sore and she "could not use for 48 hours". Subsequently on 16-DEC-2006, the patient recovered from fever T > 100, arm was very sore and could not use arm for 48 hours. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1290
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Computerised tomogram, Head injury, Headache, Syncope
Symptom Text: Information has been received from a physician concerning a female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2007 the patient fainted after the administration of Gardasil. It was reported that this patient may have fainted while on the way to the car and hit her head at an unspecified area. Medical attention was sought and the patient's mother was requesting a computed axial tomography because the patient was experiencing bad headaches. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1291
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Head injury, Headache, Syncope
Symptom Text: Information has been received from a physician concerning a female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of HPV. On approximately 12-FEB-2007 the patient fainted after the administration of HPV. It was reported that this patient may have fainted while on the way to the car and hit her head at an unspecified area. Medical attention was sought and the patient's mother was requesting a computed axial tomography because the patient was experiencing bad headaches. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1292
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a family nurse practitioner (FNP) concerning numerous patients who on an unspecified dates were vaccinated with HPV (lot # not reported). Subsequently, the patients experienced stinging and sore arm after the vaccination. The outcome of the stinging and sore arm was not reported. No other information was available at the time of reporting. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1293
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of Gardasil (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1294
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of HPV (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1295
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of HPV (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1296
Days 0
State WA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Body temperature increased, Chills, Hyperhidrosis, Inappropriate schedule of drug administration, Influenza, Lymphadenopathy, Musculoskeletal stiffness, Myalgia
Symptom Text: Initial and follow-up information has been received from a nurse practitioner concerning a 60 year old white female cigarette smoker (40 cigarettes per day) with hypothyroidism who on 30-OCT-2006 was vaccinated, into the right "glute" with a first dose of HPV (lot # 653978/0955F). Concomitant therapy included levothyroxine Na (SYNTHROID). On 04-NOV-2006 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 06-NOV-2006 the patient experienced enlarged cervical lymph nodes. Subsequently, the patient recovered. It was reported that the patient thought that she had the flu. On 12-JAN-2007 the patient was vaccinated, into the right "glute" with a second dose of HPV (lot # 654389/0961F). On 17-JAN-2007 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 19-JAN-2007 the patient experienced enlarged cervical lymph nodes. The nurse practitioner felt that the patient had an "exaggerated immune response." At the time of the report, the patient's stiff neck and myalgia and mild chills and sweats and temperature of 101 and enlarged cervical lymph nodes persisted. The patient refused her third vaccination. No further information is available. Synthroid Other Meds: body temp 11/04/06 101; body temp, 01/17/07 101; serum C-reactive 01/22/07 14.5; serum alkaline 01/22/07 106 Lab Data: History: Prex Illness: Prex Vax Illns: Hypothyroidism; Cigarette smoker


Page 1297
Onset Date Unknown
Days
State OH
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Abortion spontaneous, Drug exposure during pregnancy
Symptom Text: Information has been received from a physician, for the Pregnancy registry for Gardasil, concerning a 26 year old female with pertinent medical history and drug reactions/allergies unspecified who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported) injection. On an unspecified date, the patient was vaccinated with second dose of Gardasil (lot # not reported) injection. Concomitant therapy was unspecified. Approximately two weeks after receiving the second dose of vaccine, the patient learned that she was pregnant. The patient sought medical attention, she reported the pregnancy to the physician's office. The date of last menstrual period was not reported. The third dose of Gardasil will not be given to the patient during her pregnancy. The patient has not had any adverse experiences to date. Additional information was received from the physician who reported that the patient had a miscarriage. No further information was available at the time of reporting. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) UNK


Page 1298
Days 0
State VA
Prev Doses 0
ER VISIT, NOT SERIOUS Abortion induced, Drug exposure during pregnancy
Symptom Text: Information has been received from a licensed practical nurse concerning a 15 year old female student who on 22-JAN-2007 was vaccinated intramuscularly in the left arm with a 0.5ml first dose of Gardasil (lot #653736/0868F). On 02-FEB-2007, it was discovered that the patient was pregnant. At the time of this report, the patient's last menstrual period was unknown. The patient sought unspecified medical attention and she was referred to an obstetrician/gynecologist. A pregnancy test was performed. On an unspecified date, the pregnancy was terminated. At the time of this report, the outcome was unknown. No product quality complaint was involved. Upon internal review, pregnancy was terminated was considered to be an other important medical event. Additional information is not expected. UNK Other Meds: beta-human chorionic Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown)


Page 1299
Days 0
State FR
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Abortion missed, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Symptom Text: Information has been received from a health professional concerning a pregnant 35 year old female with a history of missed miscarriage who on 24-JAN-2007 was vaccinated intramuscularly with a first dose of Gardasil. The site of administration was not reported. concomitant therapy included Echinacea (unspecified), FUNGUSTATIN, ZIRTEK which the patient took as self medication from 12-JAN-2007 to 24-JAN-2007 because she believed she had a possible fungal infection. It was reported that the patient was unaware that she was pregnant at the time of vaccination. The first day after her last menstruation period was 31DEC-2006 and the patient's expected date of delivery was 07-OCT-2007. The patient realized that she was pregnant on 31-JAN-2007. Approximately 4 days later, the patient experienced a "missed miscarriage." This diagnosis was made by the reporting physician herself. At the time of this report, the outcome was unknown. The reporting physician specified that the miscarriage was not related to therapy with Gardasil. It was also specified that FUNGUSTATIN had not been prescribed by a physician and that it was self-administered by the patient. Upon internal review, miscarriage was considered an other important medical event. Other business partner number included E2007-01696. No further information is available. The case is closed. ZIRTEK 12Jan07 - 24Jan07, echinacea (unspecified) 12Jan07 - 24Jan07, fluconazole 12Jan07 - 24Jan07 Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: Abortion missed


Page 1300
Days 1
State MI
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Cough, Dyspnoea, Electrocardiogram normal, Heart rate increased, Middle insomnia, Nausea, Night sweats, Tachycardia
Symptom Text: History of racing heart since getting vaccine 2/20/07. Short of breath-sent to cardiologist ECG doppler normal. Back again 3/16/07 missed 5 days of school. Coughing waking at night, night sweats, nausea. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1301
Vaers Id: 274777-1 Age Gender F 14.0 VAX Detail: Type TD HEPA HPV4 Seriousness: MedDRA PT
Days 1
State NY
Manufacturer AVENTIS PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.
Lot Prev Doses AC52B014AA 5 AHAVB143BA 0 01870 1
NO CONDITIONS, NOT SERIOUS Rash erythematous, Rash generalised
Symptom Text: rash-red spots with white centers all over. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE


Page 1302
Days 0
Received Date 26-Mar-2007 Lot 02002AC 0187U
State CA
Prev Doses 0 0
ER VISIT, NOT SERIOUS Blood pressure decreased, Fall, Syncope
Symptom Text: After getting 1 Menactra vaccine to her Left deltoid and 2 HPV vaccines to her Right deltoid. Patient fainted and fell down to the floor, nonconscious. Approx 2 min she became alert and her Blood pressure 90/60. 911 was called and she was brought to hospital in stable condition. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE


Page 1303
Vaers Id: 274790-1 Age Gender F 11.0 VAX Detail: Type TDAP FLU HPV4 Seriousness: MedDRA PT
Days 3
Received Date 26-Mar-2007 Lot C2638AA U2307AA 00886
State VA
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral, Pain in extremity
Symptom Text: R arm redness, pain, swelling. Shortly after. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Adderall NONE NONE/Well child


Page 1304
Days 0
Received Date 26-Mar-2007 Lot SP 2631AA M 0688F
State VA
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Hyperhidrosis, Pallor, Presyncope
Symptom Text: BECAME DIAPHOETIC AND VERY PALE. NEAR SYNCOPE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: MIGRAINES NONE NONE


Page 1305
Days 0
State GA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin negative
Symptom Text: Information has been received from a 20 year old female with an allergy to Zomig and a history of multiple miscarriages. On 11-JAN-2007 the patient was vaccinated with her first dose of Gardasil when she was 4 and a half weeks pregnant. The patient took a urine Human chorionic gonadotropin (HCG) test in the doctor's office that said she was not pregnant, and they administered the vaccination on day. On 17-JAN-2007 the patient discovered she was pregnant. On 21JAN-2007 she had a miscarriage. Medical attention was sought. Her outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: urine beta-human 01/11/07 - Not pregnant Miscarriage Pregnancy NOS (LMP = Unknown) Drug hypersensitivity


Page 1306
Onset Date Unknown
Days
State GA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Hip arthroplasty
Symptom Text: Information has been received from a female who on 29-NOV-2006 was vaccinated with Gardasil. At the time of reporting, the patient had not yet received her second dose of Gardasil due to hip replacement surgery. Additional information has been requested. Upon internal review, hip replacement surgery was considered to be an other important medical event. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK


Page 1307
Days 0
State FR
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Agitation, Hypotension, Loss of consciousness, Nausea, Neurological examination, Tonic convulsion
Symptom Text: Information has been received from a health professional concerning a 15 year old female who on 13-MAR-2007 was vaccinated IM into the arm with a first dose of Gardasil (lot # 655376/0572F, batch # NE45050). About 5-10 minutes after the vaccination the patient developed symptoms of tonic convulsions and was unconsciousness for about 1-2 minutes. After recovery the patient developed hypotension and felt nauseas for about 20 minutes. The patient recovered completely. It was reported that the patient is tall and slim and was very excited before vaccination. It was also noted that her sister has a history of hydrocephalus and epilepsy. A neurologic check is planned. Other business partner numbers included E2007-01613. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK UNK


Page 1308
Onset Date Unknown
Days
State AZ
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a medical assistant through a pregnancy registry concerning a 19 year old female with a history of miscarriage who was vaccinated with the first dose of Gardasil. It was reported that later the patient found out that she was pregnant. The patient was 2 months pregnant at the time of the vaccination. It was reported that the patient miscarried 2 weeks after the vaccination. At the time of the report it was unknown, if the patient recovered. Upon internal review, it was determined that miscarried was an other important medical event. Additional information has been requested. UNK Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: UNK Miscarriage


Page 1309
Days 0
State MO
Prev Doses 0
Site Unknown
Symptom Text: Nausea, lightheaded x 5 min right after injection. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Get lightheaded with blood draws


Page 1310
Vaers Id: 274953-1 (S) Age Gender Vaccine Date F 06-Mar-2007 18.0 VAX Detail: Type MNQ HPV4
Days 1
State AZ
Prev Doses 0 0
ER VISIT, HOSPITALIZED, SERIOUS Back pain, Back pain, Body temperature, Bronchitis, Convulsion, Discomfort, Dizziness, Fall, Headache, Hyperventilation, Lack of spontaneous speech, Mental status changes, Nystagmus, Pyrexia, Stridor, Syncope, Tetany, Viral infection
Symptom Text: 1:30 Backache, headache, dizziness, generalized discomfort in clinic - call to facility for clarification of side effects, referred to Family Practice - developed stridor, nystagmus - transferred to facility reported at 4:30. Admitted to ICU. Discharged facility 3/9/07. 04/02/07-records received from facility-Fever and altered neurological status. Temp 101.2. Fell at clinic. Fainted. Presented to ER with nystagmus with mainly her gaze toward the right. Not speaking Hyperventilating. Fever a few days ago and had been sick with viral syndrome. PE pupils equal round reactive to light but she had nystagmus frequently every few seconds and mainly seemed with a right. Required interpreter but she had no spontaneous speech. Carpal pedal spasm. DC Summary for DOS 3/7-3/9/07. DC DX:Diseases disorders of nervous system. Convulsions, Tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago, fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Very minimal URI symptoms Done in hospital LP: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56, protein 19. WBC 16.3, 90% neutrophil. Influenza A and B negative. EEG: mildly abnormal EEG due to excessive presence of beta activity which could be drug related. The lack


Page 1311
Days 0
State PA
Prev Doses 1
Symptom Text: Lightheaded then passed out for less than 10 seconds. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1312
Days 1
State MN
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Herpes zoster
Symptom Text: Herpes Zoster of R upper chest & shoulder Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1313
Days 1
State MI
Prev Doses 2
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Symptom Text: Pt received #3 Gardasil on 2/22/07. L arm small red dot after shot. On 2/23/07 she started to get larger with raised area on 2/24/07. Size of (2) quarters, itching on/off with minimal pain. On 3/15/07 22mm bump felt under the skin but not raised. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1314
Days 0
State OR
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Herpes simplex, Nausea, Pyrexia
Symptom Text: Pt felt nauseous after receiving vaccine. Developed temperature >102. Continued with a fever 102 deg -103.5 F x 5 days. Developed "fever blisters" in mouth. Saw a provider at hospital ED. Treated with Doxycycline. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Lab work done at hospital no results available None None


Page 1315
Onset Date Unknown
Days
State MI
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration
Symptom Text: None Menactra given 2 mo early Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1316
Days 0
State NY
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Chest pain
Symptom Text: Pt received Gardasil vaccine 1/11/07 at 100PM - Developed c/o chest pain late evening & went to hospital ER. Pt brought this to our attention 3/12/07 when she was scheduled for her second vaccination - dose not given. No intervention other than Advil given in ER. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Chest Xray & EKG within normal limit, Dedimer normal Allergy Penicillin None


Page 1317
Days 1
State NY
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Back pain, Myalgia, Neck pain, Pain in extremity, Pain in extremity
Symptom Text: APPROX. 24 HOURS AFTER VACCINE BEGAN WITH MUSCULAR NECK,BACK,LEG AND ARM PAIN. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NO NO PREVICID 30 MG DAILY


Page 1318
Vaers Id: 275023-1 Age Gender M 77.0 VAX Detail:
Days 0
Received Date 16-Mar-2007 Lot 1476F 1208F
State CA
Type VARZOS HPV4
Prev Doses
ER VISIT, NOT SERIOUS Inappropriate schedule of drug administration, Incorrect drug dosage form administered
Symptom Text: Information has been received from a health professional concerning a 77 year old male with no known allergies who on 06-FEB-2007 was vaccinated IM in the right arm with a 1 ml dose of Zostavax (lot # 656412/1476F). The Zostavax was reconstituted with Gardasil (lot # 654741/1208F) and the combined product was administered to the patient. It was reported that the patient was on an unspecified concomitant medication. No symptoms have been reported. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. (therapy unspecified) Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1319
Vaers Id: 275050-1 Age Gender U Unknown VAX Detail:
Onset Date Unknown
Days
State AZ
Type VARZOS HPV4
Prev Doses
NO CONDITIONS, NOT SERIOUS Accidental exposure, Wrong drug administered
Symptom Text: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Zostavax that was reconstituted with Gardasil. No symptoms were noted. The office manager reported it was human error. The vaccine was administered by a medical assistant who was working in the office as a temp and was unfamiliar with the office and the vaccine. There was no product quality complaint involved. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1320
Days 11
State NY
Prev Doses 1
Site Unknown
Symptom Text: Day after receiving Guardasil noted hives throughout body which increased over weekend. Prescribed Keflex and Benadryl. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Othrotrecyclen Lo NONE NONE NONE


Page 1321
Onset Date Unknown
Days
State NC
Prev Doses 1
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Diarrhoea, Haematochezia, Pain, Pyrexia, Renal failure acute
Symptom Text: Information has been received from a physician concerning a 13 year old female who, on an unspecified date, was vaccinated intramuscularly with a second dose of Gardasil. Within 24-48 hours, the patient experienced fever, achiness and diarrhea. The physician reported that 1-2 days later, the patient developed blood in the stool and was admitted to the hospital. The physician reported that the patient was diagnosed with acute kidney failure and was still hospitalized. At the time of this report, the patient's fever, achiness and acute kidney failure persisted. Fever, achiness and acute kidney failure were considered to be immediately life-threatening and disabling. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1322
Days 0
State CA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Anxiety, Convulsion, Loss of consciousness, Pain
Symptom Text: Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who on 19-MAR-2007 was vaccinated with the first dose, IM, of Gardasil. The physician reported that "approximately 3 minutes after receiving the first dose of the vaccine, the patient passed out," and then "experienced a seizure that lasted approximately 2 minutes." The physician stated that the seizure was probably related to pain or anxiety, and indicated that the patient's status had improved after she received therapy (therapy unspecified). Seizure was considered to be an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1323
Days 0
State ME
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Hypoaesthesia, Paraesthesia, Paraesthesia
Symptom Text: Elbows bilateral tingling and numb. No shortness of breath, respiratory distress Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1324
Onset Date Unknown
Days
State MD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Condition aggravated, Juvenile arthritis, Varicella
Symptom Text: Spoke with patient mother 3/13/07. Patient appeared to have what was thought to be chicken pox. Her rheumatologist did bloodwork and thinks that the vaccine flared up her Juvenile rheumatoid arthritis. Mother will call back with results of test and results from visit at John Hopkins. Claritin D Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Bloodwork done by rheumatologist Amoxicillin


Page 1325
Days 2
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Erythema, Swelling face
Symptom Text: Patient received 1st dose of Gardasil on 3/21/07 no co's voiced at time of injection. On Friday evening 3/23/07 patient noted face to be red and swollen, symptoms disappeared after 2 hours. On Monday 3/26/07, pateint noted same red, swollen face after ingesting glass of white wine with dinner, again symptoms lasted about 2 hours. Patient did not take any other medication during this time frame, nor had she used any new soaps/make up. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: seasonal allergies


Page 1326
Days 0
State MA
Prev Doses
ER VISIT, NOT SERIOUS Dizziness, Fall, Head injury, Headache, Muscle twitching, Pallor, Staring
Symptom Text: Received immunizations at approximately 6:50PM, went to waiting room where brother and sister saw her fall to floor hitting her head (?left side) on a wooden playbox. They said she just stared for about 5 seconds then left arm / shoulder was twitching when RN arrived, patient was conscious and in a chair. She was pale, P68 at a FBV minutes, before 7pm, BP was 108/78, P78 standing. She was still dizzy and c/o headache, so ambulance was called. She was observed in ER and discharged home. None Other Meds: Accucheck 149, via normal EKG normal > Done at medical center Lab Data: History: Prex Illness: Prex Vax Illns: allergies - Erythromycin, Acanthosis nigricans, overweight None


Page 1327
Days 0
State AL
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Injection site rash, Rash generalised
Symptom Text: Information has been received from a registered nurse concerning a 10 year old female with a penicillin allergy who on 19-MAR-2007 was vaccinated IM with a 0.5 ml second dose of Gardasil (Lot# 654741/0013U). There was no concomitant medication. On 19-MAR-2007 the patient developed a rash all over her body, especially near the injection site. The nurse reported that the patient was given BENADRYL for the rash. The patient went to see her pediatrician who reportedly prescribed the patient with prednisone an ZYRTEC. It was also reported that the patient did not have a reaction to her first dose of Gardasil. At the tiem of the report, the patient was recovering. The nurse felt that the patient's rash was an other important medical event. Additional information has been requested. None Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy


Page 1328
Days 3
State --
Prev Doses
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Arthralgia, Arthralgia, Gait disturbance, Pain in extremity
Symptom Text: Information has been received from a physician concerning her 18 year old daughter with penicillin and sulfonamide allergy, attention deficit/hyperactivity disorder, anxiety and migraine who on 15-MAR-2007 was vaccinated, intramuscularly, with a dose of Gardasil. Concomitant therapy included TOPAMAX, STRATTERA and ZOLOFT. On 18-MAR-2007 the patient experienced "soreness in her legs" and her "knees and ankles began to hurt. "The patient took ibuprofen for the symptoms. On 20-MAR-2007, the patient was not able to attend school. It was reported that she was "not walking normally" and "walking like an old lady." Unspecified medical attention was sought. There was no laboratory or diagnostic test performed. At the time of the report, the symptoms had not resolved. The physician considered "knees and ankles began to hurt" and "soreness in her legs" to be disabling events. STRATTERA, ZOLOFT, TOPAMAX Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy; sulfonamide allergy; Attention deficit/hyperactivity disorder; Anxiety; Migraine


Page 1329
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Activities of daily living impaired, Muscle twitching, Musculoskeletal stiffness, Pain in extremity, Tourette's disorder
Symptom Text: Initial and follow-up information has been received from a Medical Assistant concerning a 17 year old female patient who on 15-MAR-2007 was vaccinated IM with her first dose of Gardasil, lot #654702/0011U. The reporter reported soon after the injection "her arm hurt really bad" and was stiff. On 16-MAR-2007 the patient developed sporadic twitching of her whole body. The reporter stated that the patient "looked as if she had Tourette syndrome. " On 17-MAR-2007 the patient was examined in the emergency room and was released a few hours later. She was examined by her primary physician and gynecologist. She had an appointment with a neurologist. She has not had any improvement in her symptoms of sporadic twitching, however arm pain and stiffness were subsiding. The reporter considered the events to be disabling because the patient was unable to perform her activities of daily living for a week. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1330
Days 2
Received Date 31-Mar-2007 Lot UNSURE
State KY
Prev Doses 2
Site Right arm
ER VISIT, NOT SERIOUS Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Oedema peripheral, Paraesthesia, Paraesthesia
Symptom Text: Gardasil give in Right Deltoid on Monday March 26. On Wed, March 28, patient reported itching, swelling and redness in Right upper arm. 4 1/2 inch by 5 inch red, swollen, hot area noted on upper right arm. Taken to see MD on Thursday March 29. Patient started on Omnicef 300mg BID, Zyrtec 10mg QD, cool compresses and Advil PRN. On Saturday, March 31, Patient becan complaints of tingling in fingers of Rt. hand. Rt. arm 3-4 cm larger than left arm. Called Dr. instructed to elavate arm and give Advil around the clock. Report increase swelling or symptoms to physician. Previcid, Yaz Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Reflux no


Page 1331
Onset Date Unknown
Days
Status Date 03-Apr-2007 Site Left arm
State NE
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Seizure anoxic, Syncope vasovagal
Symptom Text: Vasovagal response VS Reflex anoxic seizure Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1332
Days 1
Received Date 30-Mar-2007 Lot A17714A 1427F
State FL
Prev Doses 0 0
ER VISIT, NOT SERIOUS Abdominal pain, Chills, Dizziness, Headache, Pharyngolaryngeal pain, Pyrexia, Vomiting
Symptom Text: Received Gardasil and Menactra on same day 3/13/07 at a routine physician. Approximately 12 hours later, she began with fevers, chills, headache, dizziness, sore throat & abdominal pain, vomited x 1 None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Rapid Strep test (-), rapid influenza test (-) Left Choroidal fissure brain cyst - stable in size None


Page 1333
Days 0
State SC
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Injection site pain, Syncope
Symptom Text: Dizziness, Syncope recovered in few minutes. Patient also complained of severe pain at Vaccine site. Tylenol PO given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Glucose 96, B/P 104/86, Sat 99%, pulse 75 None, NKDA, H/O Reflux None


Page 1334
Days 0
Received Date 02-Apr-2007 Lot 1427F
State --
Prev Doses 0
Site Unknown
PERMANENT DISABILITY, SERIOUS Hypokinesia, Pain in extremity
Symptom Text: Information has been received from a physician concerning an 18 year old female with AMOXIL allergy who on 15-JAN-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F), IM, 0.5 ml. Concomitant therapy included hormonal contraceptives (unspecified). On 15-JAN-2007, the patient experienced prolonged left arm pain and limitation of movement secondary to arm pain following the first dose of Gardasil. No redness or swelling was noted. A shoulder xray was negative. The patient was treated with an unspecified NSAID's (non-steroidal, anti-inflammatory drug) and was referred to a neurologist. At the time of the report, the patient's prolonged left arm pain persisted and was considered to be disabling. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin allergy joint X-ray 01/15/07 negat


Page 1335
Days 0
Received Date 02-Apr-2007 Lot 0186U
State MA
Prev Doses
ER VISIT, PERMANENT DISABILITY, SERIOUS Discomfort, Hypokinesia, Injected limb mobility decreased, Injection site pain
Symptom Text: Information has been received from an RN concerning a 26 year old female patient who on 05-MAR-2007 was vaccinated IM in left deltoid with a dose of Gardasil, lot #655618/0186U. Concomitant therapy included unspecified birth control pills. The nurse indicated that the patient has experienced soreness at the injection site from the dose of Gardasil since 05-MAR-2007, and described the symptoms as "uncomfortable". The patient is a dancer and cannot lift her arm. Medical attention was sought and Advil was taken for the symptoms. The patient's symptoms have improved but they have not resolved. The nurse felt that the patient's symptoms were disabling because she was unable yo work as a dance instructor and cannot keep her arm up over her head. Additional information has been requested. hormonal contraceptives Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1336
Days 2
State CT
Mfr Report Id CT200705 Route Intramuscular
Prev Doses 0
ER VISIT, NOT SERIOUS Pruritus, Rash, Rash macular, Rash pruritic
Symptom Text: Pt seen at office on 3/26/07 c/o itchy rash to face. Reports XS began 2 days previously. Seen by DR noted macular rash face and neck and ordered Benadryl, Prn. Albuterol inhaler, Prevacid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Allergy Codeine (GI upset), HX GERD and exercise induced asthma. on 3/22/07 for epistaxis S/P trauma nose


Page 1337
Vaers Id: 275377-1 Age Gender U Unknown VAX Detail: Type HPV4 HEPA
Days 0
State IN
Lot Prev Doses 0263U 1 AHAVB129AA 1
NO CONDITIONS, NOT SERIOUS Convulsion, Syncope
Symptom Text: Syncope and short syncopal seizure after Gardasil x2 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1338
Days 22
State VA
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Anogenital warts
Symptom Text: Complained of rectal condyloma within 3 weeks of getting vaccine. No exposure there. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None exam None None


Page 1339
Vaers Id: 275428-1 (D) Age Gender Vaccine Date F 01-Mar-2007 12.0 VAX Detail: Type VARCEL HPV4 HEPA Seriousness: MedDRA PT DIED, SERIOUS
Days 6
Received Date 02-Apr-2007 Lot 0943R 0263U 1280F
State NY
Prev Doses 1 0 1
Autopsy, Myocarditis, Ventricular tachycardia
Symptom Text: presented to ED with Ventricular tachycardia. Preliminary autopsy finding of myocarditis Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: aortic and mitral valve insufficiency, unknown aetiology none


Page 1340
Vaers Id: 275438-1 (D) Age Gender Vaccine Date F 12-Mar-2007 19.0 VAX Detail: Type HPV4 DIED, SERIOUS
Days 14
State CA
Prev Doses 0
Coronary artery thrombosis, Echocardiogram abnormal, Pulmonary embolism, Sudden cardiac death, Thrombosis
Symptom Text: Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 T/C to coroners bureau to request prelim COD. Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. Letter faxed to pathology department to request final autopsy report. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1341
Onset Date Unknown
Days
State FL
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Hypotension, Loss of consciousness
Symptom Text: Patient passed out. Blood pressure remained too low for patient to get off floor for 1% 1/2 hrs. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: allergy to penicillin


Page 1342
Days 11
State MS
Type SMALL HPV4 ANTH
Manufacturer Lot WYETH PHARMACEUTICALS, INC 4020076 MERCK & CO. INC. 0011U EMERGENT BIOSOLUTIONS FAV103
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Abdominal pain, Back pain, Pyrexia, Rash pruritic
Symptom Text: 1-2 wk-fever, lower back pain, lower abdominal pain. 23-MAR-broke out in small red bumps that got bigger and itched really bad. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1343
Days 1
State PA
Prev Doses 1
Site Unknown
Symptom Text: 16 Year old female received a 2nd dose of Gardasil vaccination next morning she woke up with generalized body aches. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE None


Page 1344
Onset Date Unknown
Days
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Asthenia, Cold sweat, Dyspnoea, Injection site pain, Malaise, Sensation of foreign body
Symptom Text: Information has been received from a company representative via a physician's office concerning a 17 year old female who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, immediately following vaccination, the patient complained about injection site pain. The patient left the practice together with her mother. About 15 minutes post vaccination, the patient and her mother returned. At that time, the patient complained about feeling unwell and an intense global feeling in her pharynx. The patient felt like not being able to breath. The patient was treated with corticosteroids. After about 1 hour, the patient recovered from the global feeling in her pharynx but was asthenic and showed cold sweat. The patient was admitted to the hospital. The patient recovered after two days and was discharged from the hospital. Other business partner numbers included E2007-01818. Additional information is not expected. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1345
Vaers Id: 275511-1 Age Gender F 15.0 VAX Detail: Type IPV HPV4 DTAP Seriousness: MedDRA PT
Days 0
Received Date 03-Apr-2007 Lot Z0868 0903F Z0868
State FR
Mfr Report Id WAES0703USA05195 Route Intramuscular Intramuscular Intramuscular
Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC. UNKNOWN MANUFACTURER
Prev Doses
NO CONDITIONS, NOT SERIOUS Asthenia, Cough, Injection site pruritus, Medication error, Pruritus, Visual disturbance, Vomiting, Wrong drug administered
Symptom Text: Information has been received from a physician concerning a 15 year old female who on 22-MAR-2007 was vaccinated IM into the right arm with a first dose of Gardasil (lot# 654948/0903F; batch# NE35170). concomitant suspect therapy included given on 22-MAR-2007 included an IM into the left arm booster dose of REPEVAX (batch# Z0868). About 30 minutes later, the patient developed pruritis first at the left than at the right injection site. The patient experienced "subjective" unspecified visual disturbance for a short time. Subsequently, she vomited 5 times and experienced a dry cough and felt weak. the patient's mother brought her back to the practice. She was treated with antihistamines, prednisolone (100 mg) and inhalative salbutamol. Within about 2 hours the patient recovered. It was reported that all previous vaccinations were well tolerated. The reporter felt that pruritis at the injection site, visual disturbance, vomited 5 times, dry cough and weak were considered to be other important medical events. Other business partner numbers include: E200701842. No further information is available. The file is closed. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1346
Days 2
Status Date 05-Apr-2007 Site Left leg
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Pruritus, Skin burning sensation, Urticaria
Symptom Text: Bethany went tanning at tanning bath, has tanned previous to vaccine. Did not use sun tanning lotion. 2 hrs post tanning after showering noticed hives on chest, breasts and armpits. C/O burning and itching, pt instructed no tanning until further notice per doctor. No other c/o symptoms. Hives lasted 8 hr then disappeared. Estrostep 28 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKA None


Page 1347
Days 2
State TX
Prev Doses 0
ER VISIT, NOT SERIOUS Body temperature increased, Rash maculo-papular, Rash pruritic
Symptom Text: Patient developed itchy, maculopapular rash on the palms 2 days after Gardasil was administered. Sje also had temp of 102 which lasted less than 1 day duration. Po benadryl given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1348
Days 1
Received Date 03-Apr-2007 Lot AC52B009AA 0186U
State PA
Prev Doses 0 0
Right arm
NO CONDITIONS, NOT SERIOUS Rash papular
Symptom Text: patient developed a skin collored papular nonpruritic rash on arms and face 5 days after receiving hpv and tdap vaccines. came to the doctors to be evalauted for the rash. no other symptoms or sequelae Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none nickel and lactose allergies none


Page 1349
Onset Date 03-Apr-2007
Days 4
State ME
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Local reaction, Urticaria
Symptom Text: LOCAL REACTION WITH URTICARIA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CODEINE,SULFA,CEFZIL NO mIRENA iud


Page 1350
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Chest discomfort, Dyspnoea, Erythema, Erythema, Injection site pain, Injection site swelling, Oxygen supplementation
Symptom Text: Information has been received from a registered nurse (a school nurse), via a company representative, concerning a 16 year old female patient, who in March 2007, was vaccinated with a dose, 0.5ml, IM, of Gardasil. The nurse reported that on the following day, the patient developed swelling and pain at the injection site, chest tightness, shortness of breath and facial redness, and was transported by ambulance to the emergency room. The nurse stated that treatment included oxygen, and epinephrine injection, and prednisone. Following treatment "the patient's symptoms resolved and the patient completely recovered." The nurse considered the events to be life threatening and disabling. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1351
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician who reported that her daughter was vaccinated with her second dose of Gardasil and experienced pain during the injection. The patient stated there was no pain when she received the first dose of Gardasil. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1352
Vaccine Date 04-Apr-2007
Days 0
Received Date 04-Apr-2007 Lot 02400
State WI
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Injection site pain, Neck pain, Paraesthesia
Symptom Text: Pain from injection site extending into neck. Paresthesia in hand. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1353
Vaers Id: 275622-1 Age Gender F 17.0 VAX Detail: Type MNQ HEPA HPV4 Seriousness: MedDRA PT
Days 1
Received Date 04-Apr-2007 Lot U2209AA 1209F 0263U
Status Date 16-Apr-2007 Site Left arm Left arm
State AZ
Prev Doses 0 1 0
Right arm
NO CONDITIONS, NOT SERIOUS Asthenia, Hypotonia, Muscular weakness, Neurological examination, Pain in extremity, Physiotherapy, Urinary tract infection
Symptom Text: Pt c/o pain and weakness in Lt arm persistent since admin. of vaccine in Lt arm. Dr notes pt has decrease muscle strength in Lt arm unable to make a fist and decrease tone in Lt arm. 4/10/07 Received medical records from PCP which include vax records & reveal that on day of vax patient experienced UTI s/s, UA was done & patient started on antibiotics. Returned to PCP on 4/4/07 w/complaints of left arm weakness since vax. Exam revealed decreased left arm muscle strength. Patient was unable to make a fist w/left hand & had decreased muscle tone in left arm. Received neuro & PT referrals. Minocycline, Dafferin gel Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Dr examined referred to PT and neurology consult. None U.T.I.


Page 1354
Onset Date Unknown
Days
Received Date 04-Apr-2007 Lot 0908F U1875AA 1427F AHAVB143BA
State CO
Type VARCEL MNQ HPV4 HEPA
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS
Prev Doses 1 0 0 0
Site Right arm Right leg Left leg Right leg
ER VISIT, NOT SERIOUS Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Oedema peripheral
Symptom Text: Right upper arm swelled and turned red. Was given on ABD, steroid and pain killer about Fri PM 13/30/07. Seen again by NP - no meds given at that time. Arm by 4-1-07was red and swollen from elbow elbow to shoulder and was resolving. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1355
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Convulsion
Symptom Text: Information has been received from a medical office receptionist who saw a news report in which it was reported that a female patient who was vaccinated with Gardasil experienced a seizure. She had no further information and reported she only saw part of the news report. Upon internal review, seizure was considered an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1356
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, Foetal heart rate abnormal
Symptom Text: Information has been received from a 24 year old female with no drug reactions or allergies and no pertinent medical history who on 07-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. The patient reported that she was pregnant when she received her first injection of Gardasil. The patient reported that she did have an appointment with OB/GYN and the physician did not hear a heartbeat and she was therefore being referred for an ultrasound. The patient stated that her physician advised her to continue the injections with Gardasil, but the patient decided not to get the other two shots. Upon internal review it was determined that "physician did not hear a heartbeat" was considered an other important medical event. Additional information has been requested. None Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown)


Page 1357
Days -63
State PA
Prev Doses 1
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Arthralgia, Arthralgia, Arthralgia, Dizziness, Headache, Loss of consciousness, Vision blurred
Symptom Text: Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient's symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory - results not reported Unknown


Page 1358
Days 8
State NC
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Bone pain, Myalgia, Tendonitis
Symptom Text: myalgias, bone pain, tendonitis Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Amox, itching; hx eczema, hay fever None


Page 1359
Onset Date Unknown
Days
State NJ
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Limb discomfort, Pain
Symptom Text: c/c-pain-odd sensation in legs-first dose-adm by Gyn (MD) November 2006. 2nd dose-adm by PMD-Feb 2007- Symptoms-started Feb2-have increased since Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: labs done 3-30-2007 NONE


Page 1360
Vaers Id: 275694-1 Age Gender F 11.0 VAX Detail: Type TDAP HPV4 MNC Seriousness: MedDRA PT
Days 0
Received Date 05-Apr-2007 Lot C2659AA 0181U U2221BA
State CA
Manufacturer AVENTIS PASTEUR MERCK & CO. INC. UNKNOWN MANUFACTURER
Prev Doses
Site Unknown Left arm Right arm
NO CONDITIONS, NOT SERIOUS Asthenia, Pallor, Pyrexia
Symptom Text: Mother explained when child woke up 4-3-07 a day after immunization she noticed her skin was pale, weak and has fever. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 1361
Onset Date Unknown
Days
State FR
Mfr Report Id WAES0704POL00002 Route Intramuscular
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Peritoneal abscess, Polycystic ovaries
Symptom Text: Information has been received from a physician concerning a 13 year old female who on approximately 07-MAR-2007 was vaccinated with Gardasil. In March 2007, the patient experienced polycystic ovaries and peritoneal abscess (10 centimetres in diameter) and was hospitalized. The patient was treated with antibiotic intravenously. After treatment with antibiotic the diameter of the abscess was about 3 centimetres. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1362
Days
State MN
Prev Doses 0
Site Unknown
Symptom Text: Information has been received through the pregnancy registry from a physician concerning a female teenager who was vaccinated with a first dose of Gardasil without the knowledge that she was pregnant. It was found out that the patient was pregnant after the administration of the vaccine. Later the patient had a miscarriage. As per the reporter, the miscarriage happened "last month or so." Medical attention was sought. The patient was recovering. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP=unknown) Unknown


Page 1363
Vaers Id: 275703-1 (S) Age Gender Vaccine Date F 26-Mar-2007 Unknown VAX Detail: Type HPV4
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Abdominal pain
Symptom Text: Information has been received from a pharmacist (PharmD) concerning a female (age unknown) patient who on 26-MAR-2007 was vaccinated with a dose of Gardasil which was thought by the reporter to be her initial dose. Subsequently, on an unspecified date, the patient experienced generalized abdominal pain and was hospitalized on 29-MAR-2007 to rule out appendicitis. The pharmacist stated that all of the patient's test have come back normal but could not identify specifically what tests or labs were performed. It was noted that the patient was treated with IV fluids and pain medication as needed. At the time of this report, the patient had not recovered. No product quality complaint was involved. The reporter considered generalized abdominal pain to be an other important medical event. Additional information has been requested. Unknown Other Meds: diagnostic laboratory - normal Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1364
Days 0
State FL
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Convulsion, Emergency care examination, Fatigue, Neurological examination
Symptom Text: Information has been received from a physician concerning a 24 year old white female with no pertinent medical history who on 13-MAR-2007, at 08:30, was vaccinated, into the right deltoid, with a first dose of Gardasil (lot #657006/0188U). Concomitant therapy included ZYRTEC-D, AMBIEN CR and ALEVE. On 13MAR-2007, at approximately 19:00, the patient had a seizure while driving. The patient went to the emergency room and underwent unspecified blood tests and a computed axial tomography (results not reported). On 14-MAR-2007, the patient was too tired to go to work. The patient was advise to follow-up with a neurologist. It was recommended that the remainder of Gardasil series was held until neurologic work up was complete. Upon internal review, the patient's seizure was considered to be an other important medical event. Additional information has been requested. ZYRTEC-D; AMBIEN CR; ALEVE Other Meds: computed axial 03/13/07 - results not reported; diagnostic laboratory 03/13?/07 - results not reported Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1365
Days 41
State FR
Prev Doses 0
Site Unknown
HOSPITALIZED, SERIOUS Burning sensation, Escherichia infection, Herpes simplex, Rash pustular, Skin fissures, Superinfection, Vaginal inflammation, Vulvovaginal discomfort
Symptom Text: Information has been received from a gynaecologist concerning a 17 year old female who on 16-JAN-2007 was vaccinated with the first dose of Gardasil, (lot #654884/0902P, batch #NE24240), IM into the upper arm. Concomitant medication was not reported. On 26-FEB-2007, the patient experienced rhagades, pustules and burning feeling of vulva. On 28-FEB-2007, the patient developed severe inflammation of introitus vaginae. The patient was admitted to hospital on 02-MAR-2007. Severe herpes simplex genitalis and a superinfection with Escherichia coli were diagnosed. the patient was treated with acyclovir and antiinfectives. On an unspecified date, the following laboratory tests were performed leukocytes 6.4 nl, hemoglobulin 13.6 g/dl, hematocrit 39.5%, thrombocytes 251.000 micro/L, IgM positive, IgG positive, vaginal smear showed Escherichia coli and HSV-PCR diagnosed herpes simplex type I. On 07-MAR-2007, the patient was discharged from the hospital. Subsequently on an unspecified date, the patient recovered completely from herpes simplex type I and superinfection. On 19-MAR-2007, the patient received the second dose of Gardasil which was well tolerated (up to the reporting date). File closed. No further information is available. Unknown Other Meds: cervical smear 02?Mar07- Comment: showed Escherichia coli; HSV type and/or 2 identification PCR 02?Mar07 - Comment: Type I diagnosis made by HCRLab Data: PCR; WBC count 02?Mar07 6.4 nl; hematocrit 02?Mar07 39.5%; hemoglobin 02?Mar07 13.6 g/dl; plat Unknown History: Prex Illness: Prex Vax Illns:


Page 1366
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Guillain-Barre syndrome
Symptom Text: Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently the patient developed Guillian-Barre syndrome. At the time of this report, the outcome was unknown. Upon internal review, Guillian-Barre syndrome was considered an other important medical event. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1367
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Convulsion
Symptom Text: Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently the patient experienced "ongoing seizures". Upon internal review, the patient's seizures were considered an other important medical event. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1368
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Convulsion, Emergency care examination, Injection site irritation, Loss of consciousness
Symptom Text: Information has been received from a certified nurses aid concerning a 19 year old female who on 22-MAR-2007 was vaccinated with the first dose of Gardasil. Concomitant medication was reported as none. On 22-MAR-2007, the patient experienced burning feeling at the injection site, the patient passed out and had a seizure for about 10 minutes. An ambulance was called and the patient was rushed to the emergency room. The outcome and causality of the events were not reported. Burning feeling at the injection site, passed out and seizure were considered to be other important medical events. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1369
Vaers Id: 275712-1 (S) Related reports: 275712-2; 275712-3 Age Gender Vaccine Date Onset Date Days F 03-Apr-2007 03-Apr-2007 0 13.0 VAX Detail: Type MNQ HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Received Date 06-Apr-2007 Lot U226AA 0188U
State FL
Prev Doses 0 0
ER VISIT, HOSPITALIZED, SERIOUS Computerised tomogram abnormal, Fall, Head injury, Headache, Neck pain, Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
Symptom Text: Fainted within 10 min of receiving vaccines and fell backward and hit head on carpeted floor was unresponsive for 20-30 seconds. Complained of headache and neck pain. Transported to ER - CT showed traumatic subarachnoid hemorrhage. Transferred to PICU Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to penicillin none


Page 1370
Vaers Id: 275712-2 (S) Related reports: 275712-1; 275712-3 Age Gender Vaccine Date Onset Date Days F 02-Apr-2007 02-Apr-2007 0 13.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
State FL
Prev Doses 0
Site Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, SERIOUS Dizziness, Fall, Head injury, Intensive care
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient with a history or vasovagal response to vaccine who on 02-APR-2007 was vaccinated with a first dose 0.5 mL of Gardasil. Concomitant therapy included Menactra. On 02-APR-2007 the patient felt dizziness and fell on the ground. The patient was hospitalized in intensive care for head injury but did not require any surgery. At the time of this report patient was still in the hospital and had not recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Vasovagal reaction


Page 1371
Vaers Id: 275712-3 (S) Related reports: 275712-1; 275712-2 Age Gender Vaccine Date Onset Date Days F 02-Apr-2007 02-Apr-2007 0 13.0 VAX Detail: Type MNQ HPV4 Manufacturer AVENTIS PASTEUR MERCK & CO. INC.
Received Date 04-May-2007 Lot NULL NULL
State FL
Prev Doses 0
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, LIFE THREATENING, SERIOUS Dizziness, Fall, Head injury
Symptom Text: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00912. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a Registered nurse (R.N.) concerning a 13 year old female patient with a history of vasovagal response to vaccine who on 02-APR-2007 was vaccinated with a first dose of 0.5 mL of Gardasil. Concomitant therapy included MENACTRA. On 02-APR-2007 the patient felt dizziness and fell on the ground. The patient was hospitalized in intensive care for head injury but did not require any surgery. At the time of this report patient was still in the hospital and had not recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Vasovagal reaction


Page 1372
Vaers Id: 275734-1 Age Gender F 14.0 VAX Detail: Type TTOX HPV4 MNQ Seriousness: MedDRA PT
Related reports: 275734-2; 275734-3 Vaccine Date Onset Date Days 03-Apr-2007 03-Apr-2007 0 Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC. AVENTIS PASTEUR
Received Date 06-Apr-2007 Lot NULL NULL NULL
State MD
Prev Doses 1 0 0
ER VISIT, NOT SERIOUS Chromatopsia, Dyspnoea, Hypotension, Injection site pain, Oral pain, Pharyngolaryngeal pain, Photopsia
Symptom Text: Within one minute following injections, Bonnie experienced flashing lights in her eye; could only see in bright primary colors; had extreme trouble breathing; experienced pain in top of mouth and throat; pain at injection site; blood pressure was low. Symptoms started to subside after injection of Epinephrine and use of Nebulizer. She has no history of food or pollen allergies. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Previous reaction to DPT vaccine (seizure)Previous reaction to dental sealants (multiple canker sores, unexplained muscle twitching, rash on trunk of body)Previous reaction to sulfa based eye drops prescribed for pinkeye none


Page 1373
Related reports: 275734-1; 275734-3 Vaers Id: 275734-2 (S) Age Gender Vaccine Date Onset Date Days F 03-Apr-2007 03-Apr-2007 0 14.0 VAX Detail: Type TTOX HPV4 MNQ Seriousness: MedDRA PT Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC. AVENTIS PASTEUR
Received Date 11-Apr-2007 Lot NULL 0091U NULL
State MD
Prev Doses 0
ER VISIT, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Hypotension, Paraesthesia oral, Throat irritation, Vision blurred
Symptom Text: Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot # 655322/0091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included MENACTRA. On 3-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. "The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be disabling, life threatening, and an other medical event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Drug hypersensitivity; sulfonamide allergy Unknown


Page 1374
Related reports: 275734-1; 275734-2 Vaers Id: 275734-3 (S) Age Gender Vaccine Date Onset Date Days F 03-Apr-2007 03-Apr-2007 0 14.0 VAX Detail: Type TTOX HPV4 MNQ Seriousness: MedDRA PT Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC. AVENTIS PASTEUR
Received Date 04-May-2007 Lot NULL NULL NULL
State MD
Mfr Report Id 200701349 Route Unknown Unknown Unknown
Prev Doses 0
HOSPITALIZED, LIFE THREATENING, SERIOUS Hypotension, Paraesthesia, Paraesthesia oral, Vision blurred
Symptom Text: This case was received from another manufacturer (reference number WAES0704USA00708) on 19 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is in follow-up to report(s) previously submitted on 4/10/2007. Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot# 65532210091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included tetanus toxoid and MENACTRA. On 03-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. Follow up information from the physician indicated that at the time of vaccination, the physician was "unaware of the reactions the patient had experienced following exposure to the pertussis vaccine and sulfa as these occurred when the patient was a small child." The physician clarified that he did not consider the events to be life threatening, but confirmed that the patient would not receive additional doses of Gardasil. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be life threatening, and an other medical event. Additional has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Drug hypersensitivity to pertussis; Sulfonamide allergy


Page 1375
Days 1
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Arthralgia, Arthralgia, Arthralgia, Dizziness, Groin pain, Headache, Loss of consciousness, Pain, Physiotherapy, Vision blurred
Symptom Text: SYMPTOMS: Groin/hip, knee, ankle pain (began following Gardasil Vaccine Shot #1 12/18/06; severely worsened following Gardasil Vaccine Shot #2 2/2/07) Light-headedness, increased headaches (began following Gardasil Vaccine Shot #1; increased following Gardasil Vaccine Shot #2) Episodes of blurred vision (occasional episodes Jan thru present 2007) One episode of "blacking out" while in shower (Feb 2007) Swelling in knees TREATMENT: Been under the care of orthopaedic sports medicine doctor since 2/2/07 Had series of Xrays. hips, knees, ankles --- nothing out of the ordinary shown Participated in 6 weeks physical therapy --- pain increased to point of discontinuing PT at suggestion of physical therapist and orthopaedic doctor Had blood work done. --- nothing out of the ordinary shown Met with Dr. neurologist 3/20/07 --- office tests show nothing out of the ordinary. prescribed change in diet and charting of headaches. follow-up appt in early May Began Ibuprofen therapy (4x per day for 2 weeks) for swelling and hips/knees/ankles as prescribed by orthopaedic doctor on 3/21/07. follow-up appt 4/6/07. Next step: schedule appointment with rheumatologist; begin physical therapy again as prescribed by orthopaedic doctor Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1376
Days 64
State IL
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a consumer and a licensed practical nurse, through the pregnancy registry, concerning a 23 year old female, who was vaccinated on 28-SEP-2006 with the first dose of Gardasil, and on 28-NOV-2006 with the second dose of Gardasil (Lot # 653735/0688F). There was no concomitant medication. The nurse reported that on 26-FEB-2007 (consumer reported as 13-MAR-2007, "some time after"she received the second dose) the patient had a miscarriage. The date of the last LMP was approximately 31-JAN-2007 ("late January"). According to the consumer, lab diagnostic tests included "several blood tests, ultrasounds, vaginal probe" (results not provided). On 29-MAR-2007, the third dose of Gardasil (Lot # 654389/0961F) was administered to the patient, and the nurse reported the patient "was fine" at that visit. The miscarriage was considered to be an other important medical event. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 1/31/2007) Diagnostic laboratory 02/26/07, gynecological 02/26/07, ultrasound 02/26/07


Page 1377
Onset Date Unknown
Days
State FR
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Generalised erythema, Injection site discolouration, Pruritus generalised
Symptom Text: Information has been received from a gynaecologist concerning a 17 year old female with a history of contraception use who on 23-JAN-2007 was vaccinated with Gardasil (lot # 654884/0902F; batch # NE24240) into the left upper arm (number in the series not reported). Concomitant therapy included hormonal contraceptives (unspecified) for systemic use. On 23-JAN-2007, the same day, the patient experienced generalized pruritus and redness, She was treated with antihistamines and recovered on 24-MAR-2007. On an unspecified date in 2007, the patient developed a "white spot" (diameter approximately 4 cm) in the area of the injection site . At the time of reporting, the white spot was ongoing. This was supposed to be a "persisting damage". The events were ongoing to be serious as Other Important Medical Events. File closed. Other business partner numbers included: E2007-01992. No further information is available. hormonal contraceptives (unspecified) Unk - Unk Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: Contraception


Page 1378
Days 1
State CO
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Head injury, Nausea, Vertigo
Symptom Text: Patient reported "dizziness", "room spinning", some nausea symptoms beginning 11 hours after administration of vaccine. Dizziness woke patient during the night due to severity. Symptoms were continuing at time of discussion with patient at approximately 56 hours after administration. Symptoms worsen with position change, movement. Patient also reports striking top of head in a swimming pool approximately 4 hours after receiving vaccination. Patient will see MD if symptoms do not improve. None known Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None known None


Page 1379
Days 0
State AL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Headache
Symptom Text: 1 1/2 hr after patient received Gardasil injection, pt developed "worse headache I ever had." lasting several hours. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none


Page 1380
Days 0
Received Date 09-Apr-2007 Lot AC52B015A 1208F 12142AA
State OK
Manufacturer GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Anxiety, Fall, Loss of consciousness, Syncope
Symptom Text: Approx 2-3 min after vaccine admin, pt experienced syncope episode with 2-3 sec loss of consciousness and fall to ground from own height. Pt had not eaten that day and had expressed anxiety re: immuniz. prior to event vs immediately after event BP-110/70; P-130/min, R-24/min, O2 sat 98%. Placed pt in recumbent position and gave her mild to drink. Fs OS-109 mg/dl. Fully recovered w/in 10 min BP-100/70; P-88/mm; R-16/mn O2 Sat 99%. Recovered at 11:55 in stable condition. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1381
Days 0
State MO
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Dyspnoea, Hyperhidrosis, Pharyngeal oedema
Symptom Text: Within 1 hr after pt left office per pt she experienced dizziness, sweating, SOB and throat swelling. Pt had to use albuterol inhaler. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Zyrtec, Albuterol inhaler none Asthma, Seasonal Allergies none


Page 1382
Days 2
Received Date 09-Apr-2007 Lot NULL 0960F 1213F
State NC
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site induration
Symptom Text: 5cc of erythema/induration right u pper arm. Claritin, cool compresses. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none obesity none


Page 1383
Days 9
Received Date 09-Apr-2007 Lot 1149F C2492BA U1892AA 0962F
State MI
Type VARCEL TDAP MNQ HPV4
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses 1 0 0 0
Site Left arm Right arm Left arm Left arm
Symptom Text: On 3/23/07, had "bump" with 2 smaller bumps" on labia. 3-24-07 another appeared, but 'first was almost gone" Referred to private physician. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1384
Days 0
Received Date 09-Apr-2007 Lot U1932AB 0188U
State FL
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Dizziness, Fatigue, Gait disturbance, Hypotension, Pallor, Syncope
Symptom Text: Dizziness, pt stated that she was feeling tired, faint, could not walk, almost passed, pale face, low blood pressure. But she was conscious the whole time. The whole episode happened about 10 minutes after receiving the vaccines. She was monitored in the office until she was feeling better. She walked out of the office at 1230 PM. Received the shots at 1140. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood Glucose (normal) None/NKDA


Page 1385
Days 0
Received Date 09-Apr-2007 Lot U2117AA 1427F
State FL
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Fall
Symptom Text: At the check out patient was standing and then fell on the floor was taken to the room. She was awake, alert, vital signs were normal, stayed in the room for 1520 minutes and left when she felt better. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1386
Days 7
State PA
Prev Doses 0
Site Unknown
ER VISIT, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS Feeding disorder, Movement disorder, Tic
Symptom Text: Information has been received from a physician concerning a 15 year old female patient with Opitz syndrome (hypertelorism-hypospadias), Turner's syndrome and migraines who was on 12-MAR-2007 vaccinated with a first dose of Gardasil, lot #654389/0961F (dose not reported). Concomitant therapy included TOPAMAX, fentanyl and other "unknown medications". On 19-MAR-2007 the patient developed a movement disorder characterized by "verbal and bodily" tics. On 20-MAR-2007 patient was hospitalized and treated with IV fluids. Unspecified laboratory tests were normal. She was seen by a neurologist who felt her tics were volitional because she could stop them when asked. Another neurologist felt the tics were not volitional because they occurred in her sleep. At the time of this report, the patient had not recovered. The physician considered the events to be disabling since she was unable to feed herself. Additional information has been requested. (therapy unspecified), fentanyl, TOPAMAX Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Turner's syndrome; Migraine; Hypertelorism Unknown


Page 1387
Days 0
State IN
Prev Doses 2
ER VISIT, NOT SERIOUS Loss of consciousness, Skin laceration
Symptom Text: Student received Gardasil at 1500 on 4/2/07 - tolerated vaccine well - returned to dorm - subsequently passed out in dorm bathroom causing laceration to head. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic to Ceclor None


Page 1388
Onset Date Unknown
Days
State TX
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Arthralgia, Arthralgia, Arthralgia, Musculoskeletal pain, Pain in extremity
Symptom Text: On 3-24 07 patient developed pain on her left shoulder /left elbow/left knee / left shin/and left ankle (no arthritis) (injection was left arm) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Acne Yeast vaginitis Gynazole vaginal cream


Page 1389
Days 0
State CA
Prev Doses 0
Symptom Text: 10 minutes after administration of Gardasil in left deltoid, patient reported feeling a little dizzy. She was seated and instructed to hold her head down between her knees, with some improvement. Vital signs included B/P 76/50 (left arm) [B/P from 20 minutes earlier was 98/70]. Patient was monitored for 45 minutes, given Gatorade 12 oz and 16 oz water. Symptoms of dizziness completely resolved, with persistent stable B/P in the 90s/60s, both arms, sitting and standing. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKA/NKDA UTI


Page 1390
Days 4
Received Date 11-Apr-2007 Lot 03844 00014
State OH
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Rash, Urticaria
Symptom Text: Broke out with rash and hives 4-7-07 x 3 days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Med allergy to Sulfa


Page 1391
Vaers Id: 275961-1 Age Gender F 16.0 VAX Detail: Type TDAP HEPA HPV4 Seriousness: MedDRA PT
Days 18
Received Date 10-Apr-2007 Lot AC52B014AA AHAVB143BA 0187U
State NJ
Manufacturer GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.
Prev Doses 5 0 0
ER VISIT, NOT SERIOUS Grand mal convulsion, Headache, Hypoaesthesia, Nausea
Symptom Text: 22 Days after receiving the above vaccines, she experienced numbness in her right hand and a headache and nausea. The next morning those symptoms were resolved. After being awake for 10 minutes she had a grand mal seizure. Duration 2-3 minutes. Emergency evaluation revealed a normal exam. PMH significant for epilepsy. Dx 11/05 on Lamictal last seizure 1/06. Lamictal Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: EEG --> B/L abnormal activity Epilepsy, recurrent headaches None


Page 1392
Days 10
State NY
Prev Doses
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Diplopia, Optic neuritis, Vision blurred
Symptom Text: Information has been received from a licensed practical nurse concerning a 16 year old female with no pertinent medical history who on 29-JAN-2007 was vaccinated, intramuscularly , into the left deltoid, with a 0.5 ml dose of Gardasil (lot #"1424K"). There was no concomitant medication. On 08-FEB-2007 the patient developed optic neuritis, blurred vision and double vision and was hospitalized. The patient was discharged from the hospital on 13-FEB-2007 when her vision returned to normal. At the time of the report, the patient was recovering under the care of a retinoligist. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown None


Page 1393
Vaers Id: 275990-1 (D) Age Gender Vaccine Date F Unknown Unknown VAX Detail: Type HPV4
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
DIED, ER VISIT, SERIOUS Death, Thrombosis
Symptom Text: Information has been received from a physician's assistant (PA), via a company representative, concerning a female patient who was vaccinated (date unspecified) with a dose of Gardasil the PA reported that "the patient died of a blood clot 3 hours after getting the Gardasil vaccine." The PA clarified that the patient was not vaccinated at her office. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1394
Onset Date Unknown
Days
State TN
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Cervical dysplasia, Cervical dysplasia, Condition aggravated
Symptom Text: Information has been received from a physician concerning a 19 year old female patient, sexually active for less than 1 year, who in December 2006 was vaccinated with a first dose of Gardasil. A papanicolaou smear (PAP) test was done on the same day as the vaccination and the results showed cervical intraepithelial neoplasia (CIN) 2 or 3. After her second injection with Gardasil vaccine (yeast) she required conization due to the rapid development of CIN. Human Papillomavirus (HPV) types were unknown. The physician felt that rapid development of CIN was an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sexually active; Cervical intraepithelial neoplasia II colposcopy, Pap test 12/??/06 - Results showed CIN 2 or 3


Page 1395
Onset Date Unknown
Days
State TN
Prev Doses 0
Site Unknown
EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS Stevens-Johnson syndrome
Symptom Text: Information has been received from a physician concerning a friend of a friend's 11 or 12 year old daughter who on approximately 04-MAR-2007 ("about 1 month ago") was vaccinated with a first dose of Gardasil. In approximately March 2007, the patient developed Stevens-Johnson Syndrome and was hospitalized. Her recovery status was unknown at the time of the report. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1396
Days 0
State VA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Computerised tomogram normal, Dizziness, Fall, Head injury, Loss of consciousness, Neck injury, Pyrexia
Symptom Text: Information has been received from a licensed practical nurse (LPN), via company representative, concerning a 16 year old female patient with a sulfonamide allergy, who on 26-Mar-2007 was vaccinated with a dose of 0.5ml, IM, of Gardasil (Lot # 656372/0243U). Concomitant therapy included LOESTRIN. The nurse reported that on 26-MAR-2007, "about 15 minutes" after the vaccination, the patient felt dizzy, passed out, "hitting her face and head as she fell." The patient was taken to the ER, and was treated wit intravenous fluids and TYLENOL. A computed tomography (CT) was performed to evaluate for head and neck injury; the CT result was negative. The nurse added that the patient also developed a low grade fever (date not specified). At the time of this report, the nurse indicated that the patient had recovered from the events. Felt dizzy, passed out, hitting her face and head as she fell, and low grade fever were considered to be an other important medical event. Additional information has been requested. LOESTRIN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sulfonamide allergy Head computed axial 03/26/07 - Negative


Page 1397
Onset Date Unknown
Days
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Erythema multiforme
Symptom Text: Information has been received from a pediatrician concerning an adolescent female who was vaccinated, intramuscularly, into the upper arm, with a first dose of Gardasil. Approximately 3 week after the vaccination the patient experienced erythema exsudativum multiforme and was hospitalized. She was treated with intravenous corticosteroids. Subsequently, the patient recovered (exact duration not reported). No further information is available. Other business partner numbers included E2007-02193. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown None


Page 1398
Days 2
State --
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Abdominal pain, Mental disorder, Nausea, Vomiting
Symptom Text: A 17-year-old female who was brought to the emergency room because of progressively worsening right-sided abdominal pain since the day before her admission. She developed some nausea and had emesis in the emergency room. No previous history of abdominal pain. Additionally, she had received an injection of Gardasil three to four days prior to onset of these symptoms. She has no fever and no chills, No chest pain. Nausea and vomiting, as stated. No diarrhea. She did have a normal bowel movement yesterday. Her periods had been regular until she was started on Depo-Provera. No fever. No chills. No significant weight changes. No history of diabetes. Mental health problems as stated earlier. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Her blood pressure is 118/79, temperature 36.7, pulse 81 and respirations 22. HEAD, EARS, EYES, NOSE AND THROAT Unremarkable. Conjunctivae are pink. Buccal mucosa are moist. No cervical lymphadenopathy. Thyroid not palpable. CHEST Clear to Her medical history includes a long psychiatric history with anxiety and panic disorder, posttraumatic stress disorder and attachment disorder. No known medication allergies. The family history is not known. She is adopted. She has been adopted since age 5. No history of alcohol or tobacco.


Page 1399
Days 0
State WI
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Injection site pain, Neck pain, Paraesthesia
Symptom Text: Pain from injection site extending into neck. Paraesthesia in hand. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 1400
Onset Date Unknown
Days
State OH
Last Edit Date 18-Apr-2007 Other Vaccine HPV4 UNK
Prev Doses 2
Site Right arm
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration, Medication error
Symptom Text: Inadvertently gave the 3rd dose 2 days after the 2nd dose (of Gardasil). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None ANA (+), arthritis None


Page 1401
Days 0
State OR
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Pyrexia, Rash, Urticaria
Symptom Text: Moderate Fever, widespread rash/hives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Effexor XR 150 mg; Lexapro 10 mg; Ortho Evra Patch None Allergy Augmentin and Penicillin None


Page 1402
Days 2
State AZ
Mfr Report Id Route Unknown Intramuscular Subcutaneously
Type SMALL HPV4 ANTH
Manufacturer Lot WYETH PHARMACEUTICALS, INC 4020076 MERCK & CO. INC. 0637F EMERGENT BIOSOLUTIONS FAV106
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Diarrhoea, Erythema, Insomnia, Lymph node pain, Lymphadenopathy, Nausea, Pruritus, Pyrexia, Rash generalised, Vomiting
Symptom Text: 29 Mar 07 developed rash all over body that lasted approx. 3 days/ took benedryl or claritin for releif. 3Apr 07 lymph nodes became tender and enlarged. 5 Apr 07 lymph nodes hot, red, sore, and itchy accompanied by nausea, vomiting, diarrhea, and fever that desipated on 8 Apr 07. some lymph nodes are still enlarged and have had a hard time sleeping through the night since I received the vaccinations. Macrobid- UTI preventative, Naproxen- PRN for pain Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none Med allergies: Morphine, Codeine, Demoral, Penicillin none


Page 1403
Days 0
State FL
Prev Doses 0
ER VISIT, NOT SERIOUS Anxiety, Confusional state, Crying, Fall, Head injury, Loss of consciousness
Symptom Text: APPROXIMATELY 10 MINUTES AFTER VACCINE ADMINISTRATION CLIENT PASSED OUT FALLING AND HITTING HER HEAD. CLIENT AROUSED IN A FEW SECONDS. VITAL SIGNS CHECKED. APPROXIMATELY 20 MINUTES LATER CLIENT REPORTED FEELING ANXIOUS AND CONFUSED, CRYING, AMBULANCE CALLED NONE KNOWN Other Meds: TRANSFERRED BY AMBULANCE TO MORTON PLANT HOSPPER MOTHERS REPORT: CLIENT GIVEN IV FLUIDS AND CT SCAN. MOTHER REPORTS Lab Data: CT SCAN NORMAL BUT DID NOT R/O OR CONFIRM CONCUSSION CLIENT RELEASED FROM HOSPITAL AROUND NOON. MOTHER REPORTS ED RECOMMEN NONE KNOWN History: Prex Illness: Prex Vax Illns: NONE KNOWN


Page 1404
Days 0
Received Date 11-Apr-2007 Lot 1300F 0011U
State RI
Type VARCEL HPV4
Prev Doses 1 0
NO CONDITIONS, NOT SERIOUS Blood pressure decreased, Hyperhidrosis, Pallor, Pharyngolaryngeal pain, Syncope, Tremor
Symptom Text: 2-3 min after receiving vaccination while standing had syncopal episode, sweaty, shaking sore throat white lips after 5-10 mins. 12 cups of H2O felt better BP 90/60 BP normal taken prior to exam 106/62 P 80 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none anaphylaxis to bees (epi pen) none


Page 1405
Days 0
State RI
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Hypotension, Loss of consciousness
Symptom Text: Passed out in hallway after receiving vaccine. BP 90/30 then elevated to 98/60 took 15 mins to he able to sit up BP normal taken prior to exam 94/60 P 84 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none Ceclor allergy (rash) none


Page 1406
Days 0
State RI
Type VARCEL HPV4
Prev Doses 1 0
NO CONDITIONS, NOT SERIOUS Blood pressure normal, Fall, Heart rate normal, Syncope
Symptom Text: Syncopal episode appr 5-7 mins after administration of IM Gardasil. Fell at our check out window with no alerts anyone- BP 116/80 BP normal/prior to exam 120/80 P. 92 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1407
Days 0
State RI
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Hyperhidrosis, Hypotension, Pallor, Syncope
Symptom Text: Administered vaccine with on incidents. Suddenly with in 2-3 mins. became faint, sweaty, pale layed pt down on exam table. Responded immediately BP 98/56 AP 68. Observation, cool drink rest no further incidence-discharged with mom (did not drug herself). Doxycycline 1xd on/off for ache Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none


Page 1408
Onset Date Unknown
Days
State MO
Prev Doses 1
Symptom Text: Left arm started hurting 3 days after HPV #2 administration. Continued with pain in arm 1 month after administration of shot Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ultrasound None None


Page 1409
Days 0
State FL
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Areflexia, Gait disturbance, Incorrect route of drug administration, Muscular weakness, Muscular weakness, Pain, Paraesthesia, Sciatic nerve neuropathy, Sensory disturbance, Similar reaction on previous exposure to drug
Symptom Text: Information has been received from a physician concerning a 15 year old female with migraines and tension headaches who in January 2007, was vaccinated intramuscularly into the right leg (also reported as "buttocks") with a first dose of Gardasil. Concomitant therapy included amytripaline (manufacturer unknown and rizatriptan benzoate. In March 2007, a second dose of Gardasil was administered intramuscularly into the left leg (also reported as "buttocks"). The physician reported that "a few days to a week after each dose the patient developed a sciatic neuropathy". It was further reported that the neuropathy of the right leg had resolved completely over a few weeks (approximately January 2007 or February 2007). The neuropathy of the left leg had improved, but has not resolved. The physician noted that the patient was still having weakness in the left leg and loss of deep tendon reflex at the level of the left ankle. She also had sensory complaints and tingling when touched at the lateral distal lower extremity. The pain was improved however. The patient was reported to still have a limp. It was also reported that the patient was able to attend school but was unable to participate in physical activities due to the sciatic neuropathy. The physician felt that the patient's experiences were disabling. Additional information has been requested. amitriptyline hydrochloride,MAXALT(RIZATRIPTAN BENZOATE) Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: Migraine, Tension headache


Page 1410
Days 0
State CO
Site Unknown
NO CONDITIONS, NOT SERIOUS Agitation, Inappropriate schedule of drug administration, Underdose
Symptom Text: Initial and follow up information has been received from a health professional concerning a 39 year old whit female patient with NKDA and with HPV and with a family history of breast cancer (mother) who on 07, Nov 2006 was vaccinated with a second IM dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654540/0800F) into the left deltoid. It was reported that the patient jerked her arm away and the needle came out of the patient's arm and did not received a full dose of the vaccine. It was reported that it was "hard to tell how much of the injection was lost." "A 1/3 of the injection came out of the patient's arm and what is left in the vial." It was recommended that the patient get re-vaccinated with dose number 2. The patient was "upset for the inconvenience" and the patient decided to discontinue the injection because she had a "bad experience", she already had HPV and she had trouble getting to the office. No symptoms were noted. A first dose of HPB rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0696F) was given IM into the deltoid on 05, Sep 2006. Additional information is not expected. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Family history of cancer; Papilloma viral infection


Page 1411
Onset Date Unknown
Days
State FL
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, Nausea, Otitis media
Symptom Text: Information has been received from a registered nurse concerning a 24 year old female who on 13, Sep 2006 and 08, Nov 2006 was vaccinated intramuscularly with a first and second 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0640F). There was no concomitant medication. In approximately November 2006, the patient became pregnant about 3 weeks before she was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient's last menstrual period was 15, Oct 2006 and her estimated due data is 22, Jul 2007. No symptoms were noted. The patient sought unspecified medical attention. Other medications used during pregnancy included amoxicillin (+) clavolanate potassium (AUGMENTIX) started on 28, Nov 2006 875mg, twice a day for otitis media, ampicillin started on 04, Dec 2006 500 mg once a day administered for nausea due to amoxicillin (+) clevulanate potassium (AUGMENTIN), and prenatal vitamins started on 28, Nov 2006. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1412
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site erythema, Injection site pruritus, Injection site swelling
Symptom Text: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who in December 2006 (before Christmas) was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), injection 0.5 mL. Concomitant medication was not reported. Subsequently, on an unspecified date, the patient experienced redness, swelling and itching at injection site. The patient sought unspecified medial attention. The outcome of the event was not reported. Additional information has been requested. unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1413
Onset Date Unknown
Days
State NY
Site Unknown
NO CONDITIONS, NOT SERIOUS Medical device complication
Symptom Text: Information has been received from a health professional who reported that a prefilled syringe (Lot # 654540/1162F) malfunctioned and the vaccine sprayed across the room. The patient did not miss being vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1414
Days 0
Received Date 09-Apr-2007 Lot 653938/0954
State NC
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Drug exposure during pregnancy, Nausea, Pregnancy
Symptom Text: Information has been received as part of a pregnancy registry from a nurse practitioner concerning a 16 year old female with food allergies to coconut and mushrooms and a of history migraines, streptococcal infection and pharyngitis who on 20, Nov 2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL by intramuscular injection, first dose (lot# 6539381/0954F). Concomitant medication included (CLARITIN) and (NASONEX). On 20, Nov 2006, the patient indicated that her last period was one week ago (13, Nov 2006). On 05, Dec 2006, the patient was seen in an clinic with complaints of nausea and dizziness and had a positive urine pregnancy test at that time. On 11, Dec 2006, the patient underwent and ultrasound which revealed that she was 7 1/2 weeks pregnant. CRL 10.4 mm, positive fetal heartbeat. Additional information is not expected Claritin, Nasonex Other Meds: Ultrasound, 12/11/2006, CRL 10.4 mm, positive fetal heartbeat, 7 1/2 weeks pregnant. Urine beta-human , 12/05/2006 posit Lab Data: History: Prex Illness: Prex Vax Illns: Migraine; Streptococcal infection; Pharyngitis; Pregnancy NOS (LMP = 10/05//2006) Food allergy


Page 1415
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Fatigue, Fatigue, Ocular hyperaemia
Symptom Text: Information has been received from a nurse practitioner concerning a 38 year old female with colitis ulcerative and no allergies who on 22, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 22, Jan 2007 the patient had eye redness of the white of the eye, tiredness, fatigue and lightheadedness. As of 05, Feb 2007, the patient's symptoms continued. Additional information has been requested. None Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: Colitis ulcerative


Page 1416
Days 0
State TN
Site Right arm
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration, No adverse effect
Symptom Text: Information has been received from a registered nurse concerning a 14 year old female with no pre-existing conditions who on 29, Nov 2006, was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 28, Dec 2006, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654389/0961F) IM right arm 30 days after the 1st dose. At the time of the vaccination, the patient had no illness. The patient did not experience adverse effects. No additional information is expected. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1417
Days 0
State AL
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Incorrect route of drug administration, No adverse effect
Symptom Text: Information has been received from a nurse that on 16, Feb 2007, they administered a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) in a patient's hip. No adverse event was reported. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1418
Onset Date Unknown
Days
State KS
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician via a company representative concerning a female patient who was vaccinated with the first dose. 0.5 ml, IM, of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient "developed hives all over her body." At the time of this report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1419
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Inappropriate schedule of drug administration, Injection site pain
Symptom Text: Information has been received from a nurse practitioner (NP) concerning a 40 year old female who on 27, Feb 2007 was vaccinated with the first dose, 0.5 ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast). concomitant therapy included estrogens (unspecified. On 27, Feb 2007, "starting a short time after her first dose, "the NP reported that the patient experienced pain at the injection site. At the time of this report, the patient was recovering from the event. The patient sought unspecified medical attention. Additional information has been requested. estrogens (unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1420
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Anaemia, Dizziness, Laboratory test
Symptom Text: Information has been received from a nurse practitioner concerning a female who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) first dose. Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On approximately 15, Feb 2007, the patient experienced continuing dizziness when administered HPV rL1 6 11 16 18 VLP vaccine. A blood test was performed and the patient was found to be anemic. The nurse practitioner was unsure whether to continue further series with HPV rL1 6 11 16 18 VLP vaccine. Unspecified medical attention was sought. As of 01, Mar 2007, the patient's continuing dizziness and anemic persisted. Additional information has been requested. DEPO-PROVERA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory , anemic Unknown


Page 1421
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Facial palsy
Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). One day post vaccination with HPV rL1 6 11 16 18 VLP vaccine (yeast, the patient developed facial palsy (not further specified). The patient outcome was not reported. Additional information is not expected. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1422
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Facial palsy
Symptom Text: Information has been received from a physician concerning a patient who was vaccinated with Gardasil. Concomitant therapy included influenza virus vaccine (unspecified). One day post Gardasil, the patient developed facial palsy (not further specified). The patient outcome was not provided. Additional information is not expected. influenza virus vaccine Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1423
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female who was vaccinated intramuscularly with Gardasil (LOT# 656049/0187U). Subsequently the patient experiences an 8 inch rash on hip area. The patient sought medical attention. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1424
Days 0
State IL
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure fluctuation, Decreased appetite, Dehydration, Dizziness, Headache, Pain, Pain in extremity, Somnolence, Syncope
Symptom Text: Information has been received from a consumer concerning her 14 year old daughter who on 12-FEB-2007 was vaccinated with Gardasil (lot # not reported) 0.5 ml IM. There was no concomitant medication. On 12-FEB-2007 the patient experienced her arm hurting really bad after getting the injection and she developed a headache. Three days after the injection, on 15-FEB-2007, the patient experienced fainting, dizziness, headaches, "dehydrating", not eating, everything kind of hurts, and she only wanted to sleep. Her blood pressure was not steady and was all over the place. Medical attention was sought. Orthostatic test was performed. At the time of reporting, the patient had not recovered. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic procedure 02/15?/07 - "orthostatic test" None


Page 1425
Days 1
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a 24 year old female, with no pertinent medical history, who on 26-FEB-2007 was vaccinated with Gardasil (LOT# 654702/0011U). There was no concomitant therapy. On 26-FEB-2007, within 24 hours of Gardasil administration, the patient experienced a rash on her abdomen. The patient had phoned the office to report the rash. The rash was not seen by the nurse practitioner or physician. No prescription medication therapy was provided to the patient. Subsequently, the patient recovered in 1 day. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1426
Days 0
State CA
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Bone pain, Chills, Dyspnoea, Inappropriate schedule of drug administration, Lethargy, Myalgia, Rash
Symptom Text: Information has been received from a physician concerning a 27 year old female with no known drug allergies and a history of a left thrombosis (2001), loop electrosurgical excision procedure for mild dysplasia (06-DEC-2006) and a pregnancy (2001) who was vaccinated intramuscularly on 27-NOV-2006 with the first dose of Gardasil (Lot # not provided). On 27-FEB-2007 the patient was vaccinated intramuscularly in the right deltoid with the second dose of Gardasil (Lot # 654702/0011U). Five to eight hours post vaccination the patient developed a rash on right shoulder that spread up to her neck, myalgia, lethargy, chills, bone aching and mild shortness of breath. It was reported that 48 hours later, the patient returned to her physicians office who recommended treatment with Benadryl. The physician reported that the patient did not take the Benadryl. It was reported that the rash as resolving and the patient. The physician reported that the patient was seen again in his office on 01-MAR-2007 and was still experiencing lethargy and bone pain. The physician also reported that the patient did not have any adverse effects after that the first of Gardasil. He states that he was unsure if the third dose of Gardasil will be administered. Additional information has been rechecked. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Thrombosis leg; Loop electrosurgical excision procedure; Dysplasia; Pregnancy


Page 1427
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse concerning a female who in February 2007, was vaccinated IM with 0.5 ml Gardasil. In approximately February 2007, the patient developed a flesh-colored, dry, flakey, itchy rash on her face a couple days after administration of Gardasil. The rash resolved in about 5 days. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1428
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Alopecia, Myalgia
Symptom Text: Information has been received from a pediatrician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced muscle aches and hair loss. On 02-MAR-2007, the patient was going to the pediatrician's office for evaluation. the pediatrician reported that the vaccine was administered by the patient's OB/GYN. No further information is available. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1429
Days 0
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Hypoaesthesia oral
Symptom Text: Information has been received from a certified medical assistant concerning a 22 year old female with an allergy to gluten or wheat who on 02-JAN-2007 was vaccinated intramuscularly with a 0.5 ml (first dose of Gardasil) (lot 654389/0961F). The CMA reported that the patient's tongue felt numb for several days after her first dose of Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Gluten intolerance; Food allergy


Page 1430
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Oedema peripheral, Urticaria
Symptom Text: Information has been received from a physician assistant concerning a 15 year old "healthy individual" female who on approximately 23-FEB-2007, was vaccinated with Gardasil first dose. On approximately 23-FEB-2007 (also reported as about a week after Gardasil was administered, the patient experienced swelling and hives in her extremities area. The reporting physician assistant does not treat this patient and did not want to be contacted. The treating physician works in the same office as the reporter but also did not want to contacted as the physician did not feel the events were related. No lab or diagnostic tests were performed. Unspecified medical attention was sought. As of 02-MAR-2007, the patient's swelling and hives in her extremities persisted. No further information is available. Unknown Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1431
Days 4
State IL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Erythema, Pyrexia, Rash erythematous, Rash pruritic
Symptom Text: Information has been received from a physician concerning a 17 year old female who on 22-FEB-2007 was vaccinated with a first dose of Gardasil. On approximately 26-FEB-2007, the patient developed fever of 101F that lasted for several days. On approximately 28-FEB-2007, the patient developed a red, itchy rash on the upper body from the waist up. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: body temp 02/26/07 101 F Unk


Page 1432
Onset Date Unknown
Days
State TX
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Nodule on extremity, Oedema peripheral, Pruritus
Symptom Text: Information has been received from a physician concerning a 23 year old female who in December 2006, was vaccinated into the left arm with a 0.5mL first dose of Gardasil. Subsequently, on an unspecified date, the patient developed a swollen arm (reported via company representative). The physician also reported that the patient developed a "nodule on the left arm under the skin, "a pouch, which intermittently becomes itchy." (date not reported). At the time of the report, the patient had not recovered. The patient sough unspecified medical attention. Additional information is not available. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk


Page 1433
Days 0
State IN
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 22 year old female with an allergy to tetracycline who on 12-JAN-2007 was vaccinated IM with a 0.5 mL first dose of Gardasil (Lot# 653650/0697F). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On 12-JAN-2007 the patient developed a 102 degree fever later that evening. Subsequently, the patient recovered. Additional information has been requested. Depo-Provera Other Meds: body temp 01/12/07 102 Lab Data: History: Prex Illness: Prex Vax Illns: Allergic reaction to antibiotics


Page 1434
Onset Date Unknown
Days
State IL
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Herpes zoster
Symptom Text: Information has been received from a pharmacist concerning a 20 year old female with pertinent medical history not reported and drug reactions/allergies reported as none who on an unspecified date was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast), 0.5 ml, IM. Concomitant medication was not reported. Approximately on week after vaccination, the patient reported that she experienced shingles. The outcome and causality of the event was not reported. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1435
Days 0
State SC
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician via a company representative concerning a "very nervous" 17 year old female who on approximately 26, Feb 2007 ("earlier this week") was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On approximately 26, Feb 2007 ("after injection") the patient fainted. The patient sought unspecified medical attention and was reported as recovered (date not specified). Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Nervousness


Page 1436
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician's assistance concerning a female who on 01-MAR-2007 was vaccinated with Gardasil. On 01-MAR-2007, the patient experienced a little blood at injection site when Gardasil was administered. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested. Unknown Other Meds: Unk Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1437
Onset Date Unknown
Days
State OH
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Bronchospasm, Dyspnoea
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with 0.5 ml of Gardasil. Subsequently the patient experienced bronchospasm and shortness of breath. The patient was noted to be under a lot of stress "lately". Subsequently, the patient recovered from bronchospasm and shortness of breath. Additional has been requested. Unknown Other Meds: Unk Lab Data: History: Prex Illness: Prex Vax Illns: Stress


Page 1438
Days 2
State CA
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Injection site pruritus, Injection site rash
Symptom Text: Information has been received from a 27 year old female with no allergies who had no problem with her first dose of Gardasil. On 27-FEB-2007 the patient received her second dose of Gardasil via injection. Concomitant therapy included "YAZ" (therapy unspecified). On 01-MAR-2007 the patient experienced bumps and itchiness where she received her Gardasil shot. The patient did not seek medical attention. As of 02-MAR-2007 the patient was not recovered. Additional information has been requested. [therapy unspecified] Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk Unk


Page 1439
Days 2
State PA
Site Unknown
Symptom Text: Information has been received from a physician concerning a 16 year old female with fibromyalgia, Ehlers-Danlos syndrome, migraine and insomnia and no know drug allergies who on 16, Dec 2006 was vaccinated intramuscularly with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654885/1424F). Concomitant therapy included amitriptyline hydrochloride (AMITRIPTYLIN), ramelteon (ROZEREM), cephalexin (KEFLEX) and fludrocrtisone acetate (FLORINEF). On 18, Dec 2006 (also reported as "several hours after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast)") the patient developed mild hives on her neck. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. On 19, Dec 2006 ("by the next morning") the hives resolved without treatment. No further problems were reported. No product quality complaint was involved. Additional information has been requested. AMITRIPTYLIN, KEFLEX, FLORINEF, ROZEREM Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Fibromyalgia; Ehlers-Danlos syndrome; migraine; Insomnia


Page 1440
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse (LPN) concerning her 16 year old daughter who in September 2006, was vaccinated with the first IM dose of Gardasil. Concomitant therapy included "RPN" inhaler. The LPN reported her daughter had been "growing out of rheumatoid arthritis". Within 24 hours, at 0400 hours, the patient experienced nausea and vomiting that lasted for several days. The patient was then fine. In November 2006 or December 2006, the patient received her second IM dose of Gardasil. Within 24 hours, at 0400 hours, the patient experienced vomiting and nausea that lasted for several days. Subsequently, the patient was fine. The patient did not seek medical attention. Additional information has been requested. [therapy unspecified] Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk Rheumatoid arthritis


Page 1441
Days 14
State FL
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dermatitis allergic, Pityriasis rosea, Rash, Rash, Rash generalised
Symptom Text: Information has been received from a health professional concerning a female who on 08-FEB-2007 was vaccinated intramuscularly with the first dose of Gardasil (lot # 653938/0954F). Subsequently the patient developed a rash on her arm and part of her face on approximately 22-FEB-2007. The rash spread to the rest of her body. The patient was referred to a Infectious Disease specialist and was diagnosed with allergic dermatitis and pityriasis rosea. Throat culture was negative. The patient was treated with hydroxyzine hydrochloride (Atarax). Subsequently, the rash resolved. Additional information has been requested. It was reported that another female in her school class experienced allergic dermatitis with pityriasis rosea after vaccination with Gardasil (WAES0703USA04287) Unk Other Meds: throat culture 02/07 Lab Data: History: Prex Illness: Prex Vax Illns: Unk


Page 1442
Days 0
State CA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Abdominal pain upper, Dizziness
Symptom Text: Information has been received from a physician concerning a 23 year old female patient who on 01-MAR-2007 was vaccinated with a dose of Gardasil. the patient became dizzy after receiving the injection. She also had stomach cramps when she got home. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1443
Days 0
State MA
Prev Doses
Site Right arm
ER VISIT, NOT SERIOUS Injected limb mobility decreased, Paraesthesia, Vomiting
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 21 year old female patient with asthma who on 15-DEC-2006 was vaccinated IM in her right arm with a dose of Gardasil, lot #654389/0961F. Concomitant therapy included hormonal contraceptives (unspecified) and albuterol inhaler (unspecified). The patient has had difficulty lifting her right arm since she was immunized in that arm on 15-DEC-2006. The patient also experienced tingling in her arm, nausea, and vomiting after the injection. The patient was treated with physical therapy. The patient had not recovered as of the report date. Additional information has been requested. albuterol; hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma Unknown


Page 1444
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Neuropathy
Symptom Text: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified after being administered the first dose of Gardasil, the patient developed neuropathy and was currently seeing a neurologist. The physician was not sure if the neuropathy was caused by Gardasil or not. The outcome of the event was not reported. Additional information has been requested. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk


Page 1445
Onset Date Unknown
Days
State FL
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Herpes simplex, Herpes virus infection
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated on an unspecified date with her second dose of Gardasil. Approximately a week later, the patient developed herpetic appearing lesions located on the perivulva and/or gynecological area. The patient was diagnosed with type 1 herpes simplex. The patient's outcome was known. No further information is available. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1446
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a Nurse Practitioner (N.P.) concerning a female patient in her early 20's who on an unspecified date was vaccinated with her first dose of Gardasil. Five minutes after receiving the injection, the painted fainted. She was given fruit juice. Her outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1447
Onset Date Unknown
Days
State MD
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Drug exposure during pregnancy, Vomiting
Symptom Text: Information has been received through the pregnancy registry from a registered nurse concerning a female who on 20-FEB-2007 was vaccinated with a first dose of Gardasil while she was pregnant. Subsequently the patient experienced vomiting. The patient was seen in the emergency room and treated with unspecified fluids. On an unspecified date, the patient's alpha-human chorionic gonadotropin level was 221,000. At the time of the report, the patient was 4 months gestation. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) serum alpha-human 221.0


Page 1448
Days 1
State NY
Prev Doses 2
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse concerning a 16 year old female with seasonal allergy who on 29-AUG-2006 was vaccinated intramuscularly with a first dose of Gardasil. On 06-NOV-2006, the patient was vaccinated intramuscularly with a second dose of Gardasil. It was reported that the patient received the first and second dose without incident. On 15-FEB-2007, the patient was vaccinated intramuscularly with a third dose of Gardasil. Concomitant therapy included Loratadine. On 16-FEB-2007, at midnight, the patient developed nausea and vomiting that lasted until 14:00 and the patient recovered. Unspecified medical attention was sought. Additional information has been requested. Loratadine Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Seasonal allergy


Page 1449
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female with no previous drug reactions who on 26, Feb 2007, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) first dose. On 26, Feb 2007, the patient fainted after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast). Unspecified medical attention was sought. The patient recovered from fainting the same day the vaccine was received. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1450
Days 0
State --
Site Unknown
Symptom Text: Information has been received from a pharmacist concerning a 19 year old female with pertinent medical history and drug reactions/allergies reported as none who on 05, Mar 2007 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), ( lot # 653937/0637F). Concomitant medication was reported as none. On 05, Mar 2007, 5 to 10 minutes after receiving the vaccination, the patient fainted. The patient sought unspecified medical attention. The outcome and causality of the event was not reported. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1451
Days 0
State CA
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Headache, Myalgia
Symptom Text: Information has been received from a physician concerning a 15 year old female who in February 2007, was vaccinated with a first dose of Gardasil. The physician reported that the patient developed muscle pain, headache and dizziness after receiving the first dose. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. Unk Other Meds: Unk Lab Data: History: Prex Illness: Prex Vax Illns: Unk


Page 1452
Days 7
State MO
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Feeling abnormal, Nausea, Vertigo
Symptom Text: Information has been received from a physician concerning a 21 year old female who on 04, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). ON approximately 11, Jan 2007 the patient experienced dizziness. The patient described her dizziness as a "head rush" associated with a feeling of 'fuzziness" and a sensation that she was spinning. This feeling may be accompanied by nausea with no vomiting. The dizziness was episodic and lasted for minutes to an hour or so. The dizziness was not positional and did not occur at night. The patient was seen by three physicians and underwent magnetic resonance imaging (MRI). All follow-up examinations and MRI were normal. At the time of this report, the patient had not recovered form the dizziness. Additional information has been requested. Unknown Other Meds: magnetic resonance, normal Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1453
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Vulval disorder
Symptom Text: Information has been received from a nurse practitioner concerning a 15 year old female with a history of fever of 102.5 degree a week prior to being vaccinated who on 01-MAR-2007 was vaccinated with Gardasil. In March 2007, soon after vaccination with Gardasil, the patient developed labia lesions. The patient was not sexually active. On 05-MAR-2007, the patient was seen for an office visit. The lesions were cultured and sensitivity of the lesions were negative for bacterial, fungal and viral infections. As of 05-MAR-2007, the patient's labia lesions persisted. Additional information has been requested. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic microbiology 03/07 culture and sensitivity of the lesions are negative for bacterial, fungal and viral infections Fever


Page 1454
Days 0
State OH
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Influenza like illness, Loss of consciousness, Nausea, Pain, Pain
Symptom Text: Information has been received from a physician, via a company representative, concerning a female patient, who on 05-MAR-2007 was vaccinated with the first dose of Gardasil. The physician reported that after the vaccination, the patient left the office and lost consciousness momentarily, experiences flu like symptoms including nausea, aches and pains and dizziness." It was unknown if the patient experienced fever. The patient went to the emergency room at 9:30 pm on 05-MAR-2007, "but was admitted into the hospital." Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1455
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Drug administered at inappropriate site
Symptom Text: Information has been received from a physician concerning a patient (age and gender unknown) who on 19-FEB-2007 was vaccinated with Gardasil (Lot number 654540/0800F). On 19-FEB-2007 the patient the received vaccine in the bottom. No further information is available. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk Unk


Page 1456
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration, Menstrual disorder
Symptom Text: Information has been received from a 36 female with no pertinent medical history who on 02-JAN-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. On 17-JAN-2007 the patient's "period started a week early" and has remained on that schedule. The patient did not seek medical attention. She reported that she would be a few days to a week late receiving her second vaccination of Gardasil because the physician's office was out of stock and had to order more. No further information is available. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1457
Days 0
State KS
Site Unknown
NO CONDITIONS, NOT SERIOUS Chest pain
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female smoker (1/2 pack per day) with genital warts who on 02, Mar 2007 was vaccinated intramuscularly with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654510/0962F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). On 02, Mar 2007, the patient experienced chest pain several hours post vaccination. The character and location of the chest pain was unknown. On 04, Mar 2007, the patient recovered from chest pain without medical attention on treatment. No further problem reported. Additional information has been requested. ORTHO-CYCLEN Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Smoker; Genital wart


Page 1458
Days 0
State FL
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Medication error, Wrong drug administered
Symptom Text: Information has been received from a physician concerning a 64 year old male who on 06-MAR-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil instead of Zostavax. It was reported that there was no product confusion and that is was a medication error. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1459
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant medication was not reported. Subsequently on an unspecified date, the patient did not come in for her 2nd dose of Gardasil on time and the vaccination was given after 2 months. No adverse experiences were noted. Additional information is not expected. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk


Page 1460
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Accidental exposure, Eye irritation, Vision blurred
Symptom Text: Information has been received from a medical assistant concerning a female nurse splashed Gardasil in her eyes. Subsequently, the nurse's eyes were blurry and burning (patient outcome not reported). The patient sought unspecified medical attention. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1461
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Myalgia, Pain
Symptom Text: Information has been received from a physician concerning a female who in December 2006 , was vaccinated with Gardasil 0.5 mL, injection. In December 2006, the patient experienced muscle aches all over, especially in the legs and arms. The patient's muscle aches all over, especially in the legs and arms persisted for 3 months. The patient sought unspecified medical attention. Additional information has been requested. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk


Page 1462
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Injection site swelling, Neck mass
Symptom Text: Information has been received from a physician concerning a female who on 30, Jan 2007, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient developed a large lump on her neck and swelling to her thigh at injection site after immunization with HPV rL1 6 11 16 18 VLP vaccine (yeast). Unspecified medical attention was sought. As of 03, Mar 2007, the patient's large lump on her neck and swelling to her thigh at injection site persisted. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: unknown Unknown


Page 1463
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Erythema, Eye swelling, Pruritus
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female with no pertinent medical history and no previous reactions who on 26, Feb 2007, was vaccinated with HPV rL1 06 11 16 18 VLP vaccine (yeast) first dose. Concomitant therapy included hepatitis A vaccine (inactive) (manufacturer unknown), diphtheria toxoid and tetanus toxoid all administered on the same day (26, Feb 2007). The nurse did not know if the vaccines were administered in the same arm as HPV rL1 6 11 16 18 VLP vaccine. ON 26, Feb 2007, the patient developed swelling around both eyes and her face became red and itchy. The patient did not have a fever or any other symptoms. Unspecified medical attention was sought. On 03, Mar 2007, the patient recovered from swelling around both eyes and red and itchy face. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1464
Days 0
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Erythema, Headache, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Symptom Text: Information has been received from a registered nurse concerning a 16 year old female with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 26-FEB-2007 was vaccinated with the first IM dose of 0.5 ml of Gardasil (lot # 655849/0263). There was no concomitant medication. Later in the day, on 26-FEB-2007 the patient experienced soreness at the injection site. On 27-FEB-2007 the patient developed arm redness and swelling from injection site to fingertips. There was no itching. The patient also experienced dizziness and headache throughout the day (frequency and duration unknown). The patient took ibuprofen on 28-FEB-2007 for the swelling. The swelling and redness subsided the morning of 01-MAR-2007. The patient was still reporting pain at the injection site and no swelling or redness on 05-MAR-2007. The patient was recovering from dizziness and headache. The patient had not been examined at the office since the vaccination. No lab testing was performed. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Drug hypersensitivity


Page 1465
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Cyanosis, Dizziness, Erythema, Hypoaesthesia, Hypoaesthesia, Myalgia, Rash, Skin discolouration
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Ten days after HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered, the patient developed numb fingers and hands, fingers turned red and blue, muscle aches, rash and dizziness. Unspecified medical attention was sought. As of 06, Mar 2007, the patient's numb fingers and hands and fingers turned red and blue, muscle, aches, rash and dizziness persisted. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1466
Days 0
State NE
Site Unknown
ER VISIT, NOT SERIOUS Dyskinesia, Pallor, Syncope
Symptom Text: Information has been received from a registered nurse concerning an 18 year old female patient who on 15, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 655619/1427F). Concomitant suspect vaccination included a dose of diphtheria toxoid (=) pertussis acellular 3component vaccine (+) tetanus toxoid (BOOSTRIX; and a dose of meningoxoccal ACYW conj vaccine (dip toxoid) (MENACTRA). On 15, Jan 2007, within 2 minutes after her vaccinations. the patient became pale and fainted. The nurse also reported that while unconscious, the patient had jerking motions which lasted a couple of seconds. The patient was reported to have rested in the office for 15 minutes and then went home recovered. Additional information has been requested. Unknown Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1467
Days 51
State MD
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a licensed practical nurse, concerning a 20 year old female patient, who on 03-JAN-2007 was vaccinated with the first dose, 0.5 ml, IM, of Gardasil (Lot # 654389/0961F). There was no concomitant medication. On approximately 23-FEB-2007, the patient developed "hives that started approximately 1 week before her appointment for the second dose (02-MAR-2007). The nurse added that the patient's "primary physician gave her an analgesic" (name unknown). The nurse stated that the patient"still had the hives when she came to the office" for her appointment and reported "the hives were mostly on both arms." The patient "received the second dose" of Gardasil on 02-MAR-2007. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1468
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who on 21, Feb 2007 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a single hive above her upper lip about 20 minutes after the injection. Unspecified medical attention was sought. The patient recovered. The physician did not know if the event was definitely related to the HPV rL1 6 11 16 18 VLP vaccine (yeast). Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: unknown Unknown


Page 1469
Onset Date Unknown
Days
State MO
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first and second dose of Gardasil. The patient developed a rash on her face after 1st injection. She developed a more extensive rash on her face after the 2nd injection. In both instances, the rash was isolated to only the patient's face. The physician was not planning to vaccinate the patient with the 3rd dose due to the adverse experience. Unspecified medical attention was sought. The patient was improving as of the report date. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1470
Onset Date Unknown
Days
State CT
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Activities of daily living impaired, Pyrexia
Symptom Text: Information has been received from a physician concerning a 15 year old female patient who in January 2007 was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a fever of 102.5F for 3 days after her injection. The patient missed one day of school. Unspecified medical attention was sought. The patient recovered. Additional information has been requested. Unknown Other Meds: body temp, 01/??/07, 102.5 Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1471
Days 11
State WI
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Papilloma viral infection
Symptom Text: Information has been received from a physician concerning a 16 year old female with asthma and allergy to "campha" who on 16, Feb 2007 was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), single dose vial. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS). On 27, Feb 2007 the patient was tested for HPV and the pap smear results were positive for high risk HPV. Unspecified medical attention was sought. Her outcome was unknown. Additional information has been requested. ADDERALL TABLETS, mg; ADVAIR Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: cervical smear, 02/27/2007, Positive for high risk HPV Asthma; Drug hypersensitivity


Page 1472
Onset Date Unknown
Days
State CT
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a physician concerning a 15 year old female with no pertinent medical history who was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced dizziness for three days. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Additional information has been requested. None Other Meds: None Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1473
Days 1
Received Date 12-Apr-2007 Lot 0113U U1968AA 0244U AC52B011AA
State OH
Type VARCEL MNQ HPV4 TDAP
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS
Prev Doses 1 0 0 0
Site Right arm Left arm Left arm Right arm
ER VISIT, NOT SERIOUS Injection site erythema, Injection site induration
Symptom Text: area of erythema and induration at site of second varicella immunization. 9 by 4 cm. no fever Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none AMOXIL ALLERGY NONE


Page 1474
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Head injury, Injection site pain, Injection site reaction, Injection site warmth, Loss of consciousness
Symptom Text: Information has been received from a licensed practical nurse concerning an 18 year old female who was vaccinated with Gardasil (Lot# 653735/0688F). On 12-FEB-2007, the patient lost consciousness and hit her head after receiving her first dose of Gardasil. The patient was taken to the emergency room but was not admitted. The patient also developed local site reaction. On 13-FEB-2007, the patient visited the office and complained of pain at the site and it was warm to the touch. Unspecified medical attention was sought. Subsequently, the patient recovered from lost consciousness, hit head, local site reaction and pain and warmth at injection site. Additional information has been requested. Unk Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unk Unk


Page 1475
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) first dose. Subsequently, the patient developed a rash over their entire body. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1476
Days 0
State SC
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Blood pressure increased, Headache, Loss of consciousness, Syncope
Symptom Text: Information has been received from a nurse concerning a 17 year old female who on 07-MAR-2007 was vaccinated with a 0.5 mL second dose of Gardasil. On 07-MAR-2007, the patient experienced a headache then fainted after receiving the second dose of Gardasil. The patient's blood pressure was slightly elevated while she passed out. The patient was advised to sit down for 15-20 minutes after the Gardasil was administered but refused to be seated to passing out. The patient was taken to the emergency room but refused care. At the time of this report, the outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1477
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Chest discomfort, Dyspnoea
Symptom Text: Information has been received from a physician concerning a female (age not reported) with asthma who on an unspecified date was vaccinated with the second dose of Gardasil, 0.5 ml, once, IM. Concomitant therapy included Advair and unspecified inhaler (therapy unspecified). Subsequently on an unspecified date, the patient experienced chest tightness and shortness of breath a short time after receiving her second dose of Gardasil. The physician reported that the patient self-medicated with her inhaler and her symptoms resolved. Additional information has been requested. (therapy unspecified), ADVAIR Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma


Page 1478
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a pharmacist concerning her 19 year old daughter with food allergies who in December 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included Yaz. The patient had a routine Papanicolaou (pap) test which revealed a few mild abnormal cells. A colposcopy was scheduled. The patient had not recovered as of the report date. Additional information has been requested. YAZ Other Meds: Pap test - a few mild abnormal cells Lab Data: History: Prex Illness: Prex Vax Illns: Food allergy


Page 1479
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Anogenital warts
Symptom Text: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced genital warts. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1480
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Presyncope
Symptom Text: Information has been received from a certified medical assistant concerning a 22 year old female who on 02-MAR-2007 was vaccinated with second dose of Gardasil, injection (Lot#655503/0012U). Concomitant therapy included Yaz. On 02-MAR-2007, after administration of Gardasil the patient experienced dizziness and was close to fainting. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from dizziness and close to fainting. The product quality complaint unit was not involved. Additional information has been requested. The same source also provided information concerning other patient's experiences (WAES# 0703USA04318 and WAES# 0703USA04319). YAZ Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Contraception Unknown


Page 1481
Days 20
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Arthralgia, Neck pain
Symptom Text: Information has been received from a physician concerning a 27 year old female who on an unspecified date was vaccinated with the first IM dose of Gardasil (lot# 655617/1447F). On 06-FEB-2007, the patient was vaccinated with the second IM dose of 0.5 ml Gardasil. Concomitant therapy included Percocet. On 26FEB-2007 the patient called the physician's office with complaints of neck pain. No lab testing was performed. The physician reported that patient refused to take the third dose of 0.5 ml Gardasil due to arthralgia after her second dose. Additional information has been requested. PERCOCET Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Joint disorder None0


Page 1482
Vaers Id: 276226-1 Age Gender F Unknown VAX Detail: Type TDAP HPV4
Days 0
Received Date 09-Apr-2007 Lot NULL NULL
State --
Prev Doses 0
Symptom Text: Information has been received from a nurse practitioner, via a company representative, concerning a female patient, who on 05-MAR-2007 was vaccinated with the first dose, IM, of Gardasil. Concomitant suspect therapy included Tdap. The nurse practitioner reported that "a patient who received the 1 Gardasil in one arm and the Tdap vaccine in the other arm, fainted within a few seconds after being vaccinated." The nurse practitioner states that "the patient was fine after a minute or so." The patient sought unspecified medical attention. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1483
Vaers Id: 276227-1 Age Gender M 0.3 VAX Detail: Type PNC HPV4 DTAP OPV IPV Seriousness: MedDRA PT
Days 0
State NC
Mfr Report Id WAES0703USA01289 Route Unknown Unknown Unknown Unknown Unknown
Manufacturer Lot WYETH PHARMACEUTICALS, INC NULL MERCK & CO. INC. NULL UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER NULL NULL NULL
Prev Doses 0 0 1 1
Site Unknown Unknown Unknown Unknown Unknown
NO CONDITIONS, NOT SERIOUS Diarrhoea, Medication error, Wrong drug administered
Symptom Text: Information has been received from two consumers, the mother and father of a 4 month old male infant, who on 02-MAR-2007 was vaccinated with a single dose Gardasil by mistake. Concomitant therapy included Dtap (unspecified), IPV (unspecified), OPV (unspecified) and Prevnar. The mother and father of the child reported that their son should have received the "HIB" vaccine (not specified) "but instead (was) given (Gardasil)." On 20-MAR-2007, the mother of the infant reported that the child had been experiencing "diarrhea for over a week," and reported that Pedialyte had been ordered. She added that on 16-MAR2007, the HIB vaccine was administered. The mother stated that her child did "not appear dehydrated," and continued to have "wet diapers." The patient's twin brother also experienced the events as described above after vaccination with Gardasil (WAES # 0703USA01783). Additional information has been requested. hib conj vaccine (unspecified) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Prophylaxis Unknown


Page 1484
Days 0
Status Date 09-May-2007 Site Left arm
State FL
Prev Doses 1
Symptom Text: Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient who on 10-JAN-2007 was vaccinated with her first dose of Gardasil. On 03-MAR-2007 she was vaccinated IM in her left deltoid with her second dose of Gardasil, lot #654540/0800F. Concomitant therapy included oral contraceptives (unspecified). Shortly after the administration of her second dose, hormonal contraceptives Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1485
Onset Date Unknown
Days
State NY
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Diarrhoea, Dyskinesia, Tremor, Vomiting
Symptom Text: Information has been received from an office receptionist concerning her 19 year old daughter who on an unspecified date was vaccinated with a first dose of Gardasil. The patient's arm was "shaky" after the first injection. On an unspecified date the patient received her 2nd dose of Gardasil. Subsequently, her arm was "jumpy" and she experienced vomiting and diarrhea. Unspecified medical attention was sought. The patient recovered. Additional information has requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1486
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Dizziness, Immediate post-injection reaction, Injection site irritation, Injection site pain, Presyncope
Symptom Text: Information has been received from a physician concerning a 17 year old female who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) first dose. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid administered right before HPV rL1 6 11 16 18 VLP vaccine. The patient said that while she was being administered the HPV rL1 6 11 16 18 VLP vaccine (also reported as immediately after receiving HPV rL1 6 11 16 18 VLP vaccine), she had stinging and burning sensation (at injection site) and felt as if she was going to faint or pass out. The feeling lasted for approximately fifteen minutes. Thereafter, she felt "okay" Subsequently, the patient recovered. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1487
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from an office manager concerning a female patient who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and fainted after receiving the injection. Unspecified medical attention was sought. The patient recovered. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1488
Onset Date Unknown
Days
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a rash all over the body after the injection. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1489
Days 1
State WI
Prev Doses
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning a female who on 06-MAR-2007 was vaccinated with the first IM dose of Gardasil. On 07MAR-2007 the patient experienced rash on her neck. The reporter felt that rash on her neck was not related to Gardasil. Patient outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1490
Onset Date Unknown
Days
State --
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Nausea
Symptom Text: Information has been received from an employee at a physician's office concerning a female who in December 2006, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), injection. In December 2006, the patient experienced nausea. In December 2006, therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered form nausea. Additional information is not expected. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1491
Days 8
Received Date 09-Apr-2007 Lot 654389/0961
State MA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a registered nurse concerning a 19 year old female patient with seasonal allergies who on 28, Feb 2007 was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) lot # 654389/0961F) and has not begun her period. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (AVLANE), as oral contraception, and fluticasone propionate (FLONASE). The nurse reported that the patient took her 3 weeks of active pills and usually begins her period 2 days after beginning the reminder pills. As of 08, Mar 2007 (4 days after beginning the reminder pills), the patient had not begun her period. The patient sought unspecified medical attention. Additional information has been requested. AVLANE; FLONASE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Seasonal allergy


Page 1492
Days 10
State LA
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a 24 year old female with no medical history of drug reactions/allergies who on 25, Jan 2007 was vaccinated with the first IM 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 04, Feb 2007, the patient experienced lesions on the external vaginal area. The patient contacted the physician on 26, Feb 2007. Biopsy of the lesions revealed condyloma. No treatment was provided at the time of reporting. The patient had not recovered. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: biopsy, 02/??/07; condyloma none


Page 1493
Onset Date Unknown
Days
State TX
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Menorrhagia, Menstruation delayed
Symptom Text: Information has been received from a registered nurse concerning a 22 year old "nurse" who works in the same physician's office who was vaccinated with first dose HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, her menstrual cycle did not arrive on time. Her menstruation lasted for 2 weeks and it was a heavier flow. the patient's menstrual cycle ended and then started again. The patient experienced 2 cycles in one month. After her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient's menstrual cycle arrived on time but it was a heavier flow. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1494
Onset Date Unknown
Days
State NC
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Diarrhoea, Medication error, Wrong drug administered
Symptom Text: Information has been received from two consumers, the mother and father of a 4 month old male infant, who on 02-MAR-2007 was vaccinated with single dose by mistake. Concomitant therapy included Dtap (unspecified), IPV, OPV (unspecified). The mother and father of the child reported that their son should have received the HIB vaccine (not specified) "but instead (was) given Gardasil. On 20-MAR-2007, the mother of the infant reported that the child had been experiencing "diarrhea for over a week," and reported that oral electrolyte maintenance (PEDIALYTE) has been ordered. She added that on 16-MAR-2007, the haemophilus influenza type B vaccine was administered. The mother stated that her child did "not appear dehydrated," and continued to have "wet diapers." The patient's twin brother also experienced the events as described above after vaccination with Gardasil (WAES # 0703USA01289). Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Prophylaxis Unknown


Page 1495
Onset Date Unknown
Days
State OH
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Fall
Symptom Text: Information has been received from an office manager concerning a patient who was vaccinated with a first dose of Gardasil. The patient got dizzy and fell after receiving the injection. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1496
Onset Date Unknown
Days
State NY
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Diarrhoea, Dizziness, Eye haemorrhage, Nausea
Symptom Text: Information has been received from an office receptionist concerning her 17 year old step daughter who on an unspecified date was vaccinated with first dose Gardasil. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1497
Onset Date Unknown
Days
State FL
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a patient who was vaccinated with a first dose of Gardasil. Patient developed hives within 2-3 hours of receiving the injection. The patient's outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1498
Days 0
State --
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a health professional concerning a 16 year old female who on 07-MAR-2007, was vaccinated with Gardasil (Lot# 654535/0960F). There was no local site reaction but on 07-MAR-2007, the patient became dizzy and pale. The patient had to wait 20 minutes in the waiting room before she was fine (recovered). Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1499
Onset Date Unknown
Days
State FL
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Dermatitis allergic, Pityriasis rosea, Rash generalised
Symptom Text: Information has been received from a medical assistant concerning a female with vaccinated with Gardasil. Subsequently the patient developed a rash on her arm and part of the face. The rash spread to the rest of the body. The patient was diagnosed with allergic dermatitis and pityriasis rosea. Patient outcome was unknown. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1500
Days 0
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a certified medical assistant concerning a patient with contraception who on 07-FEB-2007 was vaccinated with second dose of Gardasil (Lot#655503/0012U). Concomitant therapy included YASMIN, PAXIL and PROTONIX. On 07-FEB-2007, the patient experienced fainted (patient outcome not provided). Additional information has been requested. The same source also provided information regarding other patients' experiences (WAES#0703USA01200 and WAES#0703USA04319). YASMIN, PROTONIX, PAXIL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Contraception Unknown


Page 1501
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Presyncope, Syncope
Symptom Text: Information has been received from a certified medical assistant concerning three patients who were vaccinated with Gardasil. Subsequently, the patients were closed to fainting or fainted (patient outcomes not provided). Attempts are being made obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. The same source provided information concerning the experienced of other patients (WAES#0703USA01200 and WAES#0703USA04318). Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1502
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a patient (age and gender unknown) who on 19-FEB-2007 was vaccinated with Gardasil (Lot number 654540/0800F). on 19-FEB-2007 the patient the received vaccine in the bottom. No further information is available. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1503
Days 0
State --
Prev Doses
Site Unknown
Symptom Text: Information has been received from a physician concerning a patient (age and gender unknown) who on 19-FEB-2007 was vaccinated with Gardasil (Lot number 654540/0800F). On 16-FEB-2007 the patient the received vaccine in the bottom. No further information is available. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1504
Days 0
State IL
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Hot flush, Immediate post-injection reaction, Injection site pain, Nausea
Symptom Text: Information has been received from a registered nurse concerning a 20 year old female student who on 21-DEC-2006, at 2:00PM, was vaccinated IM, into the left deltoid, with a first dose of Gardasil (Lot# 653937/0637F). There was no illness at the time of vaccination. On 21-DEC-2006, after the injection, at 2:00PM, the patient became lightheaded and nauseated, "approximately 15 minutes". The nurse also reported the injection was very painful when vaccine contents injected into muscle and the patient had a hot flash. On 23-FEB-2007, at 3:15PM, the patient was vaccinated IM, into the left deltoid, with a second dose of Gardasil (Lot# 654389/0961F). There was no illness at the time of vaccination. The nurse reported that the patient felt a hot flash immediately post injection . The second injection was also said to be very painful when vaccine contents injected into the muscle (not from needle placement), for "five minutes". No further information is expected. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown None


Page 1505
Days 0
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Rash, Rash
Symptom Text: Information has been received from a nurse concerning a female who in February 2007, was vaccinated IM with 0.5 mL Gardasil. In approximately February 2007, the patient developed a flesh-colored, dry, flakey, itchy rash on her face a couple days after administration of Gardasil. The rash resolved in about 5 days. Additional information has been requested. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1506
Days 0
State --
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Musculoskeletal stiffness
Symptom Text: Information has been received from a nurse concerning a female who in February 2007, was vaccinated IM with 0.5 mL Gardasil. In February 2007, the morning after receiving Gardasil the patient experienced a stiff neck which was stiff for about a day. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1507
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Inappropriate schedule of drug administration, Medication error, Pain, Pain in extremity
Symptom Text: Information has been received from a certified family nurse practitioner (CFNP) concerning a 30 year old female clinic employee who in August 2006 was vaccinated with first dose of Gardasil (lot # not reported). In October 2006, the patient was vaccinated with second dose of Gardasil (lot # not reported). In February 2007, the patient was vaccinated with third dose of Gardasil (lot # not reported). In October 2006, the patient experienced stinging and sore arm after the second vaccination. The patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CFNP via telephone. The sore arm lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1508
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Inappropriate schedule of drug administration, Medication error, Pain, Pain in extremity
Symptom Text: Information has been received from a certified family nurse practitioner (CFNP) concerning a 25 year old female clinic employee who in August 2006 was vaccinated with first dose of Gardasil (lot # not reported). In October 2006, the patient was vaccinated with second dose of Gardasil (lot # not reported. In February 2007, the patient was vaccinated with third dose of Gardasil (lot # not reported). In October 2006, the patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CFNP via telephone. The sore arm lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been received. Unknown Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1509
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Diplegia, Guillain-Barre syndrome, Pain
Symptom Text: Information has been received from a pediatric physician concerning a 14 year old female who was vaccinated with a dose of Gardasil. Subsequently the patient developed Guillain-Barre syndrome which he thought was "pain and paralysis in the legs" or a "nerve-related syndrome that can last between 6 months to a year." Unspecified medical attention was sought. The patient's outcome was unknown. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1510
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
HOSPITALIZED, LIFE THREATENING, SERIOUS Angioedema, Urticaria
Symptom Text: Patient developed severe urticaria and angioedema starting about 24-48 hours after getting HPV vaccine (First dose). Patient had two E.R. visits. Needs high dose steroids to control angioedema of throat. Problem lasted ten days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No previous history of urticaria


Page 1511
Days 0
State MD
Prev Doses
Site Right arm
NO CONDITIONS, NOT SERIOUS Diarrhoea, Nausea, Pyrexia, Vomiting
Symptom Text: pt states she had fever, nausea, vomiting and diarrhea for one and half days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None fever, nausea, vomiting~Measles Mumps Rubella (Virivac)~~0~In Patient


Page 1512
Onset Date Unknown
Days
State CA
Last Edit Date 16-Apr-2007 Other Vaccine FLU
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Hypoaesthesia, Pain in extremity, Vaccine positive rechallenge
Symptom Text: intermittent numbness/pain on injection arm. started after the first vaccine 12/15/06, increased in intensity and frequency after 2nd injection 2/27/07. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: flovent, albuterol none thus far none none. the mfgr was Novartis


Page 1513
Onset Date Unknown
Days
State DE
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Injection site pain, Pain in extremity
Symptom Text: c/o soreness in arm since injection on 3/15/07. Pt came in 4/13/07 with above symptoms not note to us before this date Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none None None


Page 1514
Days 0
Received Date 13-Apr-2007 Lot AC52B009AA U2158AA 0244U
Status Date 19-Apr-2007 Site Right leg Left arm
State CA
Manufacturer GLAXOSMITHKLINE BIOLOGICALS AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses 0 0 0
Right arm
NO CONDITIONS, NOT SERIOUS Body temperature increased, Headache, Vomiting
Symptom Text: approx 1 hour after vaccine pt reported headache with temp (had tem 99 deg) per pt mom tem up to 102 approx 4 hour after I 25-vomiting approx 2 hour after I 25 none Other Meds: physical exam 4/13/07 with flu scheduled Lab Data: History: Prex Illness: Prex Vax Illns: none Temp 99 no other illnesses


Page 1515
Onset Date Unknown
Days
State MS
Prev Doses 0
Site Unknown
Symptom Text: Information has been received from a nurse practitioner concerning an approximately 16 year old female who was seen in a clinic for a migraine, and subsequently, was vaccinated IM with the first dose of Gardasil. It was reported that the patient developed seizures within 15-20 minutes of vaccination. The clinic called 911, and the nurse practitioner "believed" the patient was taken to the emergency room, although, it was unknown if the patient was hospitalized. It was also reported that the patient had no prior history of seizures, and that the patient's outcome was unknown. Upon internal review, the patient's seizure was considered to be an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Migraine Unknown


Page 1516
Days 12
State --
Prev Doses 1
Site Unknown
Symptom Text: Information has been received from a registered nurse for the Pregnancy registry for Gardasil concerning a 26 year old female who on 20-DEC-2006 was vaccinated IM with the second 0.5 mL dose of Gardasil. The patient was vaccinated with the first 0.5 mL dose Gardasil (lot # 653937/0637F) on 27-OCT-2006. Concomitant therapy included hormonal contraceptives (unspecified). In January 2007, the patient became pregnant. In March 2007, the patient had a miscarriage at 8 weeks gestation. The patient sought unspecified medical attention. Subsequently, the patient recovered. Upon internal review, the patient's miscarriage was considered to be an other important medical event. Additional information has been requested. hormonal contraceptives Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) Unknown


Page 1517
Days 1
State MA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Torticollis
Symptom Text: Gardasil #1 received 4/9/07 woke up 4/10/07 with acute torticoillis. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None 4/2/07 had a febrile illness with vomiting None


Page 1518
Days 7
Received Date 16-Apr-2007 Lot 1497F NULL
State NJ
Type VARCEL HPV4
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Rash papular, Rash pruritic, Rash vesicular
Symptom Text: Papular vesicular pruritic rash began 1 week after receiving Varivax booster. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1519
Onset Date Unknown
Days
Received Date 16-Apr-2007 Lot C2556AA 0960F U2061AA
State LA
Mfr Report Id LA070401 Route Intramuscular Intramuscular Intramuscular
Prev Doses 0 0 0
NO CONDITIONS, NOT SERIOUS Expired drug administered
Symptom Text: #2 MMR administered expired lot # MSD 0377R (3/24/07) couldn't update in LINKS Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1520
Days 3
State MA
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Pruritus, Rash, Rash macular
Symptom Text: on 3/22/07 broke out in rash on right arms, upper chest and neck itchy. on 3/23/07-examined and very faint macular rash on arms, neck, upper trunk, not urticaria Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Also on OLP (Yaz) none none


Page 1521
Days 0
State NH
Mfr Report Id NH0716 Route Intramuscular Intramuscular
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Fall, Head injury, Posturing, Staring
Symptom Text: Sitting on exam table , received vaccines Gardasil and Menactra. Got down from exam table, stood up and fell forward, hitting forehead on the wall. Nurse pivoted her onto a chair, sitting position. "Patient's eyes were open, back arched, arms straight and posturing" x approximately 3 seconds. Relaxed - still staring, not alert. Nurse and medical student placed her on exam table reclining. None Other Meds: Vital signs stable, neurologicallly stable, per provider note Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1522
Days 0
State NH
Mfr Report Id NH0717 Route Intramuscular Intramuscular
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Dizziness, Fall, Feeling hot, Head injury, Posture abnormal, Tremor
Symptom Text: Patient had lab work done 1st (hemoglobin), then received vaccines-Gardasil and Menactra left exam room, walked into waiting room and told mother she felt "hot and dizzy"; "fell over, hit head, eyes remained and open, head arched back, arms shaking. "Episode over within 1-2 minutes. Birth control "patch", Albuterol Inhaler prn Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Orthostatic vital signs done; stable Asthma, Dysmenorrhea, Migraines-Acne none


Page 1523
Days 0
Received Date 16-Apr-2007 Lot V214AA 1426F
State MA
Prev Doses
ER VISIT, NOT SERIOUS Dizziness, Fall, Head injury, Headache, Heart rate normal, Muscle twitching, Pallor, Staring
Symptom Text: Received immunizations at approximately 6:50 pm, went to waiting room where brother and sister saw her fall to floor hitting her head (L side) on a wooden play box. They said she just stared for about 5 seconds and then L arm/shoulder was twitching when RN arrived, was conscious and in a chair. She was pale, P68 at a few minutes before 7 am. BP 7:10pm 100/70. By 7:25 pm, BP was increased to 78. She was still dizzy and c/o headache, so ambulance was called. She was observed in ER and discharged home. None Other Meds: EKG nl Lab Data: History: Prex Illness: Prex Vax Illns: Allergies-erythromycin; Medical conditions-acanthosis, overweight None


Page 1524
Days 0
State GA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Convulsion, Fall
Symptom Text: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 14 year old female patient who on 23-FEB-2007 was vaccinated IM with 0.5 mL of Gardasil. On 23-FEB-2007 the patient fell to floor in a seizure like state. After 30 seconds she became conscious. Patient never had a seizure like episode before this incident. Unspecified medical attention was sought by the patient. The patient recovered the same day. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1525
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Drug administered at inappropriate site, Facial palsy
Symptom Text: Information has been received from a certified nurse midwife, via a company representative, concerning a 25 year old female patient who on 01-MAR-2007 was vaccinated in the hip, with the first dose of Gardasil (Lot #02630 - invalid). There was no concomitant medication. The nurse stated that on 27-MAR-2007, the patient developed Bell's palsy on the left side of her face, and added that the "patient's face is uncontrolled." The nurse confirmed that the patient visited the ER, but the date and details were not provided at the time of this report. Bell's palsy was considered to be disabling by the reporter. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1526
Days 11
State CO
Prev Doses 1
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Abasia, Diarrhoea, Flushing, Hypokinesia, Hypotension, Hypotension, Inflammation, Intensive care, Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Rash
Symptom Text: Severe myalgias starting 3/27/07 to the point of being unable to sit up or walk. Fever stated 4/4/07 PM. With in 1 hr of onset of fever, pt became hypotensive and had a flushing rash. She was admitted to the PICU and supported with pressors. As of 4/6/07, she is improving. No source had been identified. CK <7, BCXs neg. 04/19/07-records received from facility-DOS 4/4-4/10/07-DC DX: Hypotension. Rash. Presented with 2 week history not feeling well with significant myalgias. C/O sore throat, throat culture negative. Nausea, diarrhea. Developed progressive muscle pain. RX with dopamine. Source of infection may have been area of inflammation on back of earlobe at earring hole site. Prevacid Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: BCx x 2 Neg, Ck <7, Strep (-), ASO (-), CXR (-), Pelvic (-), UCx x 2 neg, CRP = 8.3, ESR = 36 Records received 4/19/07-CXR normal. EKG WNL. Elevated WBC. CK WNL. Blood and urine cultures negative. None None


Page 1527
Vaers Id: 276541-1 (S) Age Gender Vaccine Date F 29-Mar-2007 12.0 VAX Detail: Type MNQ HPV4
Days 0
State LA
Prev Doses 0 0
HOSPITALIZED, SERIOUS Syncope
Symptom Text: patient collapsed 15 to 20 minutes after receiving MCV4 and Gardasil vaccines. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None CBC with diff, LMP, BHCG, EKG, Echocardiogram, head CT scan, Chest X-ray, EEG Hx headaches / depression / systolic murmur


Page 1528
Days 0
State AZ
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Blood pressure decreased, Cold sweat, Dizziness, Pallor
Symptom Text: Dizziness following HPV injection, clamy, pale blood pressure went from 110/68 decreased to 80/52 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1529
Days 1098
Received Date 17-Apr-2007 Lot U1853BB 1426F
State WI
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Pityriasis rosea, Urticaria
Symptom Text: Received vaccines 3/22/07, developed hives on stomach and back 3/25/07. On 4-3-07 saw a dermatologist and was diagnosed with pityriasis rosea. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none Ortho


Page 1530
Onset Date Unknown
Days
State FL
Last Edit Date 27-Apr-2007 Other Vaccine HEPA MNQ
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dysfunctional uterine bleeding
Symptom Text: Dysfunctional uterine bleeding, without prior history of said WT = 100 lb. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Pending None None


Page 1531
Vaers Id: 276602-1 Age Gender F 18.0 VAX Detail: Type TDAP HEPA HPV4 MNQ Seriousness: MedDRA PT
Days 0
Received Date 17-Apr-2007 Lot AC526014AA AHAVB14BAA 0263U U1968AA
State PA
Manufacturer GLAXOSMITHKLINE BIOLOGICALS SMITHKLINE BEECHAM MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 0 0 0 0
Right arm Right arm Left arm
NO CONDITIONS, NOT SERIOUS Gaze palsy, Loss of consciousness, Muscle rigidity, Pallor, Staring
Symptom Text: 5 minutes after HPV vaccine was given patient became pale, her eyes rolled back in her head, and she became rigid, she lost conscious 30 seconds. When she came to she had postical s/s of a blank stare for about 5-10 seconds. She did become A x O x S. BP 116/ 78 P 64, Pulse O2 97%. Before vaccine BP 115/65 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic rhinitis, exercise induced asthma


Page 1532
Days 1
State WY
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Abasia, Asthenia, Back pain, Chills, Delirium, Dizziness, Dizziness, Fatigue, Headache, Injection site inflammation, Malaise, Neck pain, Pain, Pallor, Pyrexia, Sleep disorder, Speech disorder
Symptom Text: Laurie (mother) reports: Emily started feeling sick the morning after the shot. She started out with a mild headache, neck, and back pain. She originally attributed it to being tired. By 9:00 pm on 4-11-07 she was running a high fever, hurting everywhere, had back pain, and a severe headache. She left work early because she was so ill. She did not sleep well that night. Her fever was high enough that you could feel the heat rising from her from a foot away. She was delirious, saying strange things throughout the night. I gave her tylenol and kept cold rags on her head. During her high fever time she had chills and severe headache. The shot sight was approximately four inches in diameter. Emily was unable to walk without assistance because she was dizzy and lightheaded. She was in bed with someone watching her for two days. She was still very week on the third day and slept most of the time. The shot was given on 4-10-07. Emily missed school Thursday (4-12) and Friday (4-13). She returned today 4-16-07. She still has a headache and neck pain. She is taking tylenol every four hours so that she can function. Emily has asthma and is allergic to septra and ceclor. She also had seizures from the pertussis in DPT shots and was never able to finish the series. Emily is still tired and has no color in her face but continues to do what she has to because she needs to be at school due to graduation being only 24 days away. If Emily had been the only one to get sick we would have said she must have had something else but we know of three other students to have reactions, that is why we were concerned. If you have any questions feel free to call or e-mail. Thank you for your time, Laurie Cunningham 307-248-1262 johnlaur@silverstar.com lcunningham@lcsd2.org Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Septra and Ceclor. Reaction as a child to DTP.


Page 1533
Days 0
Received Date 17-Apr-2007 Lot 1085F AC52B007AA U2082AA 0962F
State CA
Type VARCEL TDAP MNQ HPV4
Manufacturer MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS AVENTIS PASTEUR MERCK & CO. INC.
Prev Doses 1 0 0 0
Right arm Right arm
ER VISIT, NOT SERIOUS Hypoaesthesia, Malaise, Nausea, Pain in extremity
Symptom Text: Pain and numbeness in arm for 2 days after vaccine administered. Malaise and intermittant nausea since day of vaccination. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: ZOPENEX N/A Asthma None


Page 1534
Days 26
State ME
Prev Doses 1
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Anaemia haemolytic autoimmune, Fatigue, Pallor
Symptom Text: Acute onset Autoimmune hemolytic anemia requiring IV steroids and hospitalization.Records received 4/24/07-from facility for DOS 02/13-02/15/07- DC DX: warm agglutinin autoimmune hemolytic anemia. Found at routine visit to be anemic by PCP. RX with high dose steroids. Two week HX of fatigue pallor, nauseated. 4-6 weeks prior had URI . None Other Meds: Available Records received 4/24/07-hemoglobin 5.4 and hematocrit 17. WBC 3.6. Platelets 211,000. LDH 493. Total Bilirubin 3.8. DAT Coombs found to have Lab Data: IgG anti-e antibody. Retic count elevated. Migraine Records received 4/24/07-PMH: meconium aspiration ventilated for 10 days, full term. Several episodes of dehydration as a toddler required ER visits History: and IV hydration. None Prex Illness: Prex Vax Illns:


Page 1535
Days 24
State WA
Prev Doses 1
Symptom Text: Gardasil #1 12/12/06, Gardasil #2 2/12/07 New onset seizures on 3/8/07 and 3/9/07 (non-hypoglycemic0 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Insulin, Synthroid CT/MRI normal, EEG normal IDDM, Hypothyroidism x 8yrs none


Page 1536
Onset Date Unknown
Days
State DE
Prev Doses 0
Symptom Text: C/O pain in her L arm where she got the Gardasil injection (02/10/07). Pain starts when she rotates arm inward or lift it shoulder level or above. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1537
Vaers Id: 276634-1 Age Gender F 18.0 VAX Detail: Type TDAP MMR HPV4 Seriousness: MedDRA PT
Days 1
Received Date 17-Apr-2007 Lot C2689AA 1030F 1425F
Status Date 27-Apr-2007 Site Left arm Left arm Left arm
State OR
Mfr Report Id Route Intramuscular Subcutaneously Intramuscular
Prev Doses 4 1
NO CONDITIONS, NOT SERIOUS Asthenia, Chills, Dizziness, Dyspnoea, Hyperhidrosis, Oedema peripheral, Palpitations, Pyrexia, Tachycardia, Urticaria
Symptom Text: High fever, difficulty breathing, hives, diaphoresis, chills, weakness with difficult ambulation, tachycardia, arm swollen twice it's normal size per patient report, racing heard and severe dizziness (no syncope). Dizziness persists. None Other Meds: Complete neurologic evaluation Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1538
Days 7
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Choroidal naevus, Corneal deposits, Macular oedema, Uveitis, Uveitis
Symptom Text: B Uveitis (par planitis) treatment with steroids on-going 04/25/07-records received from PCP-eye exam by ophth on 4/5/07-3 week history of blurred vision in left eye. Ocular exam slowed acuities of 20/20 OD and 20/30 OS. Right eye had a few keratic precipitates, trace vitreous cells and a nevus along the superior arcade. Left eye had keratic precipitates, 10 AC cell/hpf, much more vitreous cell, pars plana exudation and mild macular edema. DX:acute bilateral uveitis most like pars planitis. PMH: anxiety. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Evaluation for Sarcoid neg, evaluation for arthritis pending Records received 4/25/07- Labs: HLA-B27 positive. Rheumatoid factor negative. Angiotensin Converting Enzyme (ACE) 42. Anxiety Mild Pharyngitis


Page 1539
Days 2
State FR
Mfr Report Id WAES0704HUN00005 Route Intramuscular
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Thrombocytopenia
Symptom Text: Information has been received from a physician concerning a 15 year old female with a history of upper respiratory tract infection (1 week prior vaccination) who on 22-Jan-2007 was vaccinated with human papillomavirus vaccine for prophylaxis. On 24-JAN-2007 the patient experienced immuno-throbocytopenia and was hospitalized. Subsequently, the patient recovered from thrombocytopenia due to steroid treatment. The reporter felt that thrombocytopenia was not related to therapy with Gardasil. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: platelet count 24an07 24 G/l, platelet count 29Jan07 147 G/l Upper respiratory tract infection


Page 1540
Days 1
State FL
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Heart rate increased, Nausea
Symptom Text: Dizzy, Nausea, Rapid Heartbeat Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Herpes simplex virus Type 1 Concerta, Lexapro, Valtrex, Kariva


Page 1541
Days 0
Received Date 18-Apr-2007 Lot 024EU
State CA
Prev Doses 0
Symptom Text: Urticaria on lower arm after HPV immunization Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Penicillin Allergy none


Page 1542
Related reports: 276758-2 Vaccine Date Onset Date 09-Apr-2007 10-Apr-2007 Manufacturer MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC. MERCK & CO. INC.
Days 1
Received Date 18-Apr-2007 Lot 1501F U2155UA 1213F 1424F
State TX
Mfr Report Id Route Unknown Unknown Unknown Unknown
Type VARCEL MNQ HEPA HPV4
Prev Doses 1 0 0 0
Site Right arm Right arm Left arm Right arm
NO CONDITIONS, NOT SERIOUS Guttate psoriasis, Rash macular, Streptococcal identification test positive
Symptom Text: Patient returned to clinic within 24 hours of vaccination for macular rash on trunk. Macules approx 1-2 cm, annular. Pt did test (+) for strep and was diagnosed with gutate psoriasis vs vaccine rxn. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: 4/10/07 (+) Strep Acne none fever~Vaccine not specified~~0~In Patient


Page 1543
Related reports: 276758-1 Vaccine Date Onset Date 09-Apr-2007 11-Apr-2007 Manufacturer MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR
Days 2
Received Date 24-Apr-2007 Lot 1501F 1213F 1424F U2155CA
Status Date 03-May-2007 Site Left arm Left arm
State TX
Type VARCEL HEPA HPV4 MNQ
Prev Doses 1 0 0 0
Right arm Right arm
NO CONDITIONS, NOT SERIOUS Rash erythematous
Symptom Text: Pt presented with rash discrete erythematous lesion on trunk, Afebrile no lesion prior to immunization. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Acne


Page 1544
Onset Date Unknown
Days
State TX
Prev Doses 1
Site Unknown
NO CONDITIONS, NOT SERIOUS Fatigue, Headache, Nausea, Pyrexia
Symptom Text: Patient c/o nausea, fever, HA, fatigue 3 days, cont. sxs. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sulfur None


Page 1545
Vaers Id: 276797-1 (S) Age Gender Vaccine Date F 07-Mar-2007 16.0 VAX Detail: Type VARCEL HPV4 MNQ TDAP Seriousness: MedDRA PT
Days 4
Received Date 18-Apr-2007 Lot NULL NULL NULL NULL
State CA
Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC. AVENTIS PASTEUR UNKNOWN MANUFACTURER
Prev Doses 1
ER VISIT, HOSPITALIZED, SERIOUS Blister, Chapped lips, Dehydration, Fluid replacement, Injection site erythema, Injection site pain, Injection site swelling, Lip swelling, Stomatitis
Symptom Text: pt. received TDAP,HPV,VZV and MENING on 3/7/07. Within a week, one of the injections sites swelled,became painful and red. The doctor's office was notified of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fith week after injection pt was hospitalized for severe stomatitis. Please note, the pt has never suffered these symptoms before, nor has she seeked care for this problem prior to this outbreak. Pt became dehydrated and needed i.v. care. Pt had blister type lesions that started on the outside of the lips and continued to spread to the back of the throat. Pt has improved greatly and should have a full recovery. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: lip culture and blood cultures. none none


Page 1546
Days 0
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Inappropriate schedule of drug administration, Injection site irritation, Throat irritation
Symptom Text: Information has been received from a nurse concerning a 27 year old female (inappropriate age) who on 15-MAR-2007 was vaccinated with HPV. On 15-MAR2007, the patient experienced burning in her arm near the injection site as well as burning in her throat after receiving HPV. The patient sought unspecified medical attention. On 15-MAR-2007, the patient recovered from burning in her arm near the injection site and burning in her throat. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1547
Days 1
State MD
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Arthralgia, Diarrhoea, Influenza like illness, Insomnia, Myalgia, Nausea, Pyrexia, Vaccine positive rechallenge, Vomiting
Symptom Text: Noticed both after 1st and 2nd dose, within 1st 4-5 days. Flu-like symptoms. Sleeplessness, fever (100.0), nausea, vomiting, myalgia, arthralgia, diarrhea. No treatment. Flonase Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Neosporin None


Page 1548
Days 3
Received Date 19-Apr-2007 Lot AC52B065CA 0384U 1282F U1947AA
Status Date 27-Apr-2007 Site Left leg
State NC
Manufacturer GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 0 0 0 0
Right arm Left arm Right leg
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site induration, Injection site pain
Symptom Text: Lg, tender, erythematous area of approx 8x 11 cm with area of induration 6 x 7 cm, around site of Menactra vaccine. Tender area of eryth. and induration 3 x 6 cm of TDaP vaccine. Both vacc. given 3 days ago. Given Zyrtec 10 mg qd Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1549
Days 0
State AZ
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral
Symptom Text: within on half hour of administration hand, feet were red and swollen lasted several hours School nurse cooroborated, patient not seen in office by about 6 hours symptoms were gone advair/albuteral inhaler Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1550
Days 1
State CO
Type VARCEL HPV4
Prev Doses 1 0
NO CONDITIONS, NOT SERIOUS Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth
Symptom Text: 4/12/07 AT 2:15 pm noted area at injection site slight itching - looked bruised - now red and hot to touch. 50mm X 35mm. No difficulty breathing, swelling, itching on other areas. Advised Benadryl PRN. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1551
Days 0
State MI
Prev Doses 1
ER VISIT, NOT SERIOUS Balance disorder, Convulsion, Dizziness, Headache
Symptom Text: Had HPV4 immunization at approx. 6:00pm and at 9:00pm Erin had a seizure. she was taken to the Emergency department and kept overnight. This Am she is still experiencing severe dizziness with loss of balance and headache. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: High functioning Down's Syndrome none


Page 1552
Days 0
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Hypoaesthesia facial, Paraesthesia
Symptom Text: A few minutes after the vaccine was administered, the patient stated that the left side of her face felt numb and was tingly. We let her rest for 15 minutes and the feeling did not subside. I contacted her primary health provider and I gave her 50mg benadryl IM, and she had total relief of her symptoms within five minutes. She left for home with her mother in stable condition, with instructions to call us if she had any other problems. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergy to milk and peanuts. Reports heart palpitations when under stress. None


Page 1553
Days 0
State NY
Prev Doses 1
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Immediate post-injection reaction, Injection site swelling, Rash pruritic, Scab, Skin exfoliation, Skin exfoliation, Skin exfoliation, Swelling
Symptom Text: Information has been received from a registered nurse at a dermatology office, concerning a 17 year old female patient who on 20-SEP-2006 was vaccinated with the first dose of Gardasil (Lot #653736/0868F), and on 05-JAN-2007, with the second dose of Gardasil (Lot #655165/1425F) at an OB-GYN office. The nurse reported that on 05-JAN-2007, following the second vaccination, the patient, immediately got at bump on the right arm," by approximately 19-JAN-2007 ("within 2 weeks of the vaccination"), the patient's "arm was cabby, scaly and bigger, than spread to whole body and face;" the patient developed a severe rash with itching. Prior to the first visit at the dermatology office, the nurse confirmed that the patient reported she had received treatment (date not specified) from a clinic, involving 2 courses of methylprednisone and cephalexin. On 27-JAN-2007, when the patient initially visited the dermatology office, the nurse indicated that the rash "looked like a sunburn that had peeled, was swollen, flaked and scabbed." Treatment on 27-JAN-2007 included an injection of DEPO-MEDROL), MOISTEREL cream (OTC). At the time of this report, it was unknown if the patient had recovered; the patient had a follow up visit scheduled at the dermatology office for 17-APR-2007. The reporter considered the severe rash with itching, peeling, swelling, flaking and scabbing to be disabling as the patient had missed school, and also an other medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1554
Days 0
State FR
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Immediate post-injection reaction, Pain in extremity, Paraesthesia, Syncope, Tonic convulsion
Symptom Text: Information has been received from a health authority concerning a 16 year old female with reportedly no other relevant medical history, who on 12-FEB-2007w as vaccinated intramuscularly, into the left, upper, arm with Gardasil, (Lot # NE45050). On 12-FEB-2007, immediately post vaccination (P.V.), the patient complained of pain and paraesthesia in the left arm. Ten minutes p.v. the patient experienced syncope with tonic convulsion for one minute. She was hospitalized. No information regarding treatment and duration of hospitalization was given, but the time until complete recovery was reported as "6 hours". The case is closed. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown None


Page 1555
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, PERMANENT DISABILITY, SERIOUS Abasia, Asthenia, Sensory loss, Syncope
Symptom Text: Information has been received from physician's assistant concerning a 16 year old female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. it was reported that the patient was seen in the emergency room and the patient "collapsed, experienced weakness, sensory loss in extremities and the patient could not walk" after receiving Gardasil. The patient was hospitalized and the length of hospitalization was unknown. At the time of the report, it was unknown, if the patient recovered. The reporter considered collapsed, experienced weakness, sensory loss in extremities and could not walk to be disabling. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1556
Days 30
State PA
Prev Doses 1
Site Unknown
ER VISIT, LIFE THREATENING, SERIOUS Breast cancer, Breast mass, Cervical dysplasia, Cervical dysplasia, Cervical dysplasia, Condition aggravated, Human papilloma virus test positive, Mammogram abnormal, Mastectomy, Pregnancy test negative, Surgery
Symptom Text: Information has been received from a registered nurse, concerning a 26 year old female patient with a low grade squamous intraepithelial lesion, cervical dysplasia and cervical intraepithelial neoplasia-1 (18-AUG-2006), who on 16-OCT-2006 was vaccinated with the first dose, 0.5ml, IM in the left arm, of Gardasil (Lot #654540/0800F). There was no concomitant medication. On 15-DEC-2006, at an office visit scheduled to determine if she was pregnant, the patient reported that she felt a small lump in her left breast that had been there since approximately 15-NOV-2006 ("approximately one month'). The nurse added that the patient was sent to the hospital for a pregnancy test, which was negative. On 09-JAN-2007, the patient had a mammogram of the left breast which recommended that she undergo a biopsy, and on 17-Jan-2007, an ultrasound guided core biopsy of the left breast was performed; on 19-Jan-2007, the biopsy result showed "invasive and intraductal breast carcinoma." On 20-Jan-2007 the patient was vaccinated with the second dose, 0.5 ml, IM in the left arm, of Gardasil (Lot #654540/0800F). On 21-MAR-2007, a repeat Pap smear result was positive for human papilloma virus, and the nurse added that the usual treatment to remove the abnormal cells with the loop electrosurgical excision procedure (LEEP), was not performed due to the patient's breast cancer diagnosis. The nurse stated that the patient was scheduled to be seen by 2 surgeons for consideration and opinions of a bilateral mastectomy, and indicated that the patient would undergo chemotherapy following the surgery. The reporter considered the patient's invasive and intraductal breast carcinoma and/or positive human papilloma virus results to be immediately life-threatening and an other significant medical event. Additional information has been requested. None Other Meds: Breast biopsy 01/19/07 - invasive and intraductal breast carcinoma, Cervical smear 08/18/06 - ASC low grade squamous cell intraepithelial lesion Lab Data: encompassing HPV, mild dysplasia, CIN 1, cervical smear 03/21/07 - ASCUS, positive for HPV viru History: Prex Illness: Prex Vax Illns: Low grade squamous intraepithelial lesion, Cervical dysplasia, cervical intraepithelial neoplasia I


Page 1557
Vaers Id: 277122-1 (S) Age Gender Vaccine Date F 10-Apr-2007 17.0 VAX Detail: Type MNQ HPV4 HEPA Seriousness: MedDRA PT
Days 0
Received Date 20-Apr-2007 Lot 4214AA 0263U 0250U
State NJ
Prev Doses 0 0 0
Right arm
HOSPITALIZED, SERIOUS Cold sweat, Dizziness, Fall, Headache, Nausea, Somnolence, Vomiting
Symptom Text: 940 AM found patient on floor with fists lasted approx. 3-5 seconds after patient responsive but c/o headache, dizziness, nausea - BP 122/82 - skin cool and clammy - MD in to check patient c/o of same symptoms but with onset of vomiting - responsive at all times but drowsy - transported to hospital 1030 AM. (when patient fell she hit her head on a cabinet). Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CT scan - small subdural hematoma (when patient fell she hit her head on a cabinet). None Migraines


Page 1558
Days 0
State WA
Prev Doses
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site urticaria, Reaction to previous exposure to any vaccine
Symptom Text: Immediately after 3rd HPV shot she developed an approx 4 inch red/warm wheal at the injection site. This same reaction occurred years earlier with the 2nd MMR. SERTRALINE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Anorexia NONE


Page 1559
Days 7
State MI
Prev Doses 1
Site Right arm
Symptom Text: 2/20/2007 received 1st injection of HPV vaccine only noticed pain at site of injection the first day. 2nd HPV vaccine received 4/3/2007--no pain until 4/10 began to notice and has progressed to today 'muscle hurting all the way around' pain level "10" on scale 1 to 10. Thylerol Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None known Thyroid condition None


Page 1560
Days 1
State OH
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Cellulitis, Oedema peripheral, Pain in extremity
Symptom Text: Pt stated had reaction to 1s injection determined not related to Gardasil . C/O cellulitis to L finger/hand inj given in L delt. 2nd injection to R delt, pt c/o same reaction - swelling, pain to L finger/hand again - saw PCP tx for cellulitis. Atzo given. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1561
Days 7
State TX
Prev Doses 1
ER VISIT, NOT SERIOUS Oedema peripheral, Pain in extremity
Symptom Text: swelling, painful arm (L) Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1562
Days 41
State NJ
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Hypoaesthesia, Hypotonia, Lip swelling, Neurological examination normal, Oedema peripheral, Paraesthesia
Symptom Text: Received Gardasil on 03/09/2007. Patient reported numbness / tingling feeling in left fingers, arm and left swollen lip, then hands felt floppy / numb. Negative for shortness of breath, chest pain, fever, injury. Physical exam grossly normal, normal neurological exam. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NONE NONE NONE


Page 1563
Vaers Id: 277166-1 (S) Related reports: 277166-2 Age Gender Vaccine Date Onset Date F 27-Mar-2007 27-Mar-2007 26.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 0
State --
Prev Doses 1
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Uterine dilation and curettage, Vaginal haemorrhage, Vaginal haemorrhage, Vaginitis bacterial
Symptom Text: Information has been received from a physician for the Pregnancy registry for GARDASIL, concerning a 26 year old female patient with a history of first trimester miscarriage in 2006 who on 25-JAN-2007 was vaccinated IM with a first dose of HPV. The physician reported that on 27-MAR-2007 the patient was vaccinated with second dose of HPV and had a positive pregnancy test the next day. The patient presented to the physician's office on 09-APR-2007 with vaginal bleeding and a pelvic ultrasound determined that she was suffering a spontaneous abortion. She was at 6 weeks gestation. The patient was admitted to the hospital on the night of 09-APR-2007 with severe vaginal hemorrhaging and underwent an emergency dilation and curettage procedure. The patient was recovering without complication. The physician added that, on 27-MAR-2007, the patient was diagnosed with bacterial vaginosis but she did not take the prescribed treatment. The physician considered spontaneous abortion to be significantly disabling and life threatening. Additional information has been requested. Unknown Other Meds: pelvic ultrasound 04/09/07 spontaneous abortion; complete blood cell Result not reported; total serum human 03/28/07 positive Lab Data: History: Prex Illness: Prex Vax Illns: Miscarriage


Page 1564
Vaers Id: 277166-2 (S) Related reports: 277166-1 Age Gender Vaccine Date Onset Date F 27-Mar-2007 05-Apr-2007 26.0 VAX Detail: Type HPV4 Manufacturer MERCK & CO. INC.
Days 9
State --
Prev Doses 1
Site Unknown
ER VISIT, HOSPITALIZED, LIFE THREATENING, SERIOUS Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Uterine dilation and curettage
Symptom Text: Patient was apparently pregnant at time of administration of second vaccine dose. Apparently got pregnant right at or after 1st dose given. Experienced 1st trimester spontaneous abortion requiring emergency D & C hemorrhage. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: + pregnancy test Previous 1st trimester miscarriage


Page 1565
Days 0
State PA
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Convulsion, Gaze palsy
Symptom Text: Information has been received from a physician concerning a 12-15 year old (exact age unknown) female patient who in April 2007, was vaccinated with a dose of Gardasil. The patient started to convulse in front of the physician and her eyes rolled back after receiving the Gardasil. The patient received medical attention. The physician's office followed up with the patient the next day and she was doing fine. Upon internal review, convulsion was considered to be an other important medical event. The physician reported that another patient in the same age group convulsed after receiving the Gardasil. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1566
Onset Date Unknown
Days
State PA
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Condition aggravated, Convulsion
Symptom Text: Information has been received from a physician concerning a 12-15 year old (exact age unknown) patient with a history of seizure disorder (date not known), was vaccinated with a dose of Gardasil. The physician reported that the patient convulsed almost immediately after receiving the Gardasil, but he did not witness the patient's experience. The physician's office followed up with the patient next day and the patient was doing fine. Upon internal review, convulsion was considered to be an other important medical events. The physician reported that another patient in the same age group convulsed after receiving Gardasil. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Convulsion disorder


Page 1567
Days 0
State TX
Mfr Report Id TX07026 Route Intramuscular
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Deafness, Fall, Head injury, Syncope, Visual disturbance
Symptom Text: Patient was administered the HPV (Gardasil) #1 vaccine at 12:30 pm. Patient was sitting when the vaccine was administered, she got up from the exam table, standing besides the table. Patient fainted, falling on the floor, hitting her head to left side, pt. said she stopped hearing and saw everything white. She was helped from the floor and placed on exam table on a laying position. She was resting for 1 hour. Pt after 1 hour felt better and left the office walking. NONE Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NKDA Ingrown toenail


Page 1568
Days 0
State TX
Mfr Report Id TX07027 Route Intramuscular
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Dizziness, Headache
Symptom Text: 3/30/07 10:00 AM HPV vaccine was administered on her left upper arm sitting on an exam table. 2-3 minutes after administering vaccine, pt. c/o a headache and dizziness. Pt. was placed on exam table in a laying position. Fluoride Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: No test performed at the office on 3-30-07. No known drug allergies, just diagnosed with Type II Diabetes Type II Diabetes


Page 1569
Days 0
State AK
Prev Doses 1
Symptom Text: Patient developed hives on her arm and then on trunk approximately 3 hours after administration of 2nd HPV vaccine. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergic Rhinitis, Anxiety NOS, ADHD Allergic Rhinitis Paroxetine, Nasonex


Page 1570
Days 0
Received Date 23-Apr-2007 Lot U2002AC 0263U
State CA
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Injection site erythema, Injection site induration, Injection site pruritus, Reaction to previous exposure to any vaccine
Symptom Text: 12 cm x 9 cm, red , hard, itchy area, around inj site on left arm-Old imm site (from Age 3-given in Foreign country) swelled up and go "bubbly". Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none PPD


Page 1571
Days 1
Received Date 23-Apr-2007 Lot C2610AA 0188U
State KS
Prev Doses 5 0
NO CONDITIONS, NOT SERIOUS Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Neck pain, Pain
Symptom Text: Of reports sore, red, hot left upper arm, also pain on the left side of her neck, fatigue and body aches. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 1572
Days 0
State TX
Prev Doses 0
Symptom Text: Pain at injection site lasting greater than 2 months. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1573
Days 32
State NC
Prev Doses 1
Symptom Text: AFTER RECEIVING 2ND SHOT OF GARDASIL 4/12/07 SHE DEVELOPED A RASH ON THE INSIDE OF HER ARM(SAME AREN BUT OPPOSITE THE SITE OF THE INJECTION)- SHE HAD NO OTHER SIGNS SYMPTOMS- THE RASH WAS MACULOPAPULAR AND THE AREA INVOLVED WAS 4 CM IN DIAMETER orthotricyclenlo tablets Other Meds: NORMAL TEMPRATURE AND BLOOD PRESSURE Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1574
Days 30
Received Date 23-Apr-2007 Lot ?
State CA
Prev Doses 1
ER VISIT, NOT SERIOUS Arthralgia, Joint swelling, Rheumatoid arthritis
Symptom Text: Second injection of Gardasil given on November 11,2006. On December 22,2007 needed to go to the emergency room at Hospital with swollen joints in hands and extreme pain, have been diagnosed with Rheumatoid Arthritis. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Have been diagnosed with Rheumatoid arthritis none none


Page 1575
Days 0
State CA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Depressed mood, Fatigue
Symptom Text: Depressed mood and fatigue started evening of vaccine lasted 4 days. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Biaxin


Page 1576
Onset Date Unknown
Days
State TX
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Adverse event, Incorrect route of drug administration, Unevaluable event
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date, the patient was vaccinated with second dose of Gardasil (lot # not reported) SQ. Subsequently, the patient experienced an unspecified adverse event after the second dose of Gardasil was given. The patient sought medical attention and was hospitalized. The reporting physician did not administer the vaccine and was requesting follow-up from a medical team member. No further information was available at the time of reporting. Additional information has been requested. 4/26/07 CDC spoke with a nurse at the reporters office (the reporter for 277262). "While rounding in the hospital he was asked for advice about a patient (not his patient) who received her second HPV vaccine SQ instead of IM. They wanted to know if they should repeat the dose or not. He contacted Merck who responded with a letter saying they had not looked at this in the trials, etc. The patient did not have any problems.....the vaccine was administered incorrectly. " 4/27/07 Per email from CDC, "the report says the patient was hospitalized. According to your note, the pt. was NOT hospitalized. Correct? If so, we will have this corrected in VAERS." 4/27/07 Per email from CDC, "according to the nurse the patient was NOT hospitalized" 4/27/07 Per email from CDC, "Please change this in the VAERS database." Database change completed. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1577
Days 3
State TX
Prev Doses 1
Site Right arm
ER VISIT, NOT SERIOUS Burning sensation, Haematoma, Injection site swelling, Skin reaction
Symptom Text: Skin reaction w/cresent shaped burn like reaction one week after 2nd dose of Gardasil. Swollen below injection site, probable hematoma. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 1578
Days 2
State DE
Prev Doses 0
Symptom Text: Hives - no treatment Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None Loestrin


Page 1579
Days 7
State NC
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Erythema, Rash papular, Skin burning sensation
Symptom Text: redness, with pimple like sore and burning x 1 week 1 day (only reported today 4-19-07) per patient, temp 98.4 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1580
Days 0
State OR
Prev Doses 1
NO CONDITIONS, NOT SERIOUS Affect lability, Agitation, Crying
Symptom Text: Emotional agitation, sobbing for unknown reasons - very emotions for 2-3 hours. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None None


Page 1581
Days 0
Received Date 24-Apr-2007 Lot 1148F 0263U AHAVB148AA U1908AA
State PA
Manufacturer MERCK & CO. INC. MERCK & CO. INC. SMITHKLINE BEECHAM AVENTIS PASTEUR
Prev Doses 1 0 1 0
Right arm Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Hypotonia, Loss of consciousness, Muscle rigidity, Pallor, Postictal state, Staring
Symptom Text: After vaccine was given pt stated "she felt like she was going to pass out" she turned pale and rigid and lost conscious for about 1 min and when she came to she had post ictal s/s of a blank stare for about 5-10 sec and no response. Pt did walk back to a room without much time, when she got back to the room she became "limp" and needed to be lifted onto a tablet. Went home A+o x '53 None Other Meds: O2 Sat 98%, BP 102/78 Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1582
Days 0
State NM
Mfr Report Id A0647898A Route Unknown Unknown
Lot Prev Doses 0187U AHAVB148AA 0
Site Unknown Left arm
ER VISIT, NOT SERIOUS Dizziness, Loss of consciousness, Syncope
Symptom Text: This case was reported by a physician and described the occurrence of unconscious in a 12-year-old female subject who was vaccinated with Havrix, Gardasil for prophylaxis. The subject was reported to be "otherwise healthy". The subject experienced on adverse events following previous vaccinations. There were no concurrent medications. On 13 April 2007 at 11:00, the subject received the 1st dose of Havrix (.5 ml, unknown, left arm). On 13 April 2007 at an unspecified time, the subject received the 1st dose of Gardasil. On 13 April 2007, 2 minutes after vaccination with Havrix and an unspecified time after vaccination with Gardasil, the subject experienced two episodes of dizziness and fainting within five minutes of dosing. The subject was unconscious for a minute or less with each episode. This case was assessed as medically serious by manufacturer. On 13 April 2007, the events were resolved. No concurrent medication Other Meds: UNK Lab Data: History: Prex Illness: Prex Vax Illns: The subject was reported to be "otherwise healthy". The subject experienced no adverse events following previous vaccinations. Unknown


Page 1583
Days 0
State MI
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Convulsion, Dizziness, Nausea, Syncope
Symptom Text: Seizure of approx. 1 min. occured 3 hrs. following immunization, fainting twice immediately following seizure lasting approx. 30 sec. each episode, seizure of approx. 15 seconds 15 hours after immunization, severe dizziness following initial sezure lasting approx. 40 hrs. accompanied by nausea; treated in Emergency Room within 15 min. post-seizure; phenobarbital administed via IV following diagnostic tests and discharged home. Aspirin, Levothyroxine Other Meds: Blood tests and urinalysis results normal; CT scan indicated no change from previous scan. Lab Data: History: Prex Illness: Prex Vax Illns: NO HISTORY OF SEIZURES PRIOR TO THIS INCIDENT; Down Syndrome, Obstructive Sleep Apnea, Moya Moya Disease, Hypothyroidism, Wolff-ParkinsonWhite Syndrome, Arthritis secondary to hip dysplasia None


Page 1584
Days 0
State MO
Last Edit Date 26-Apr-2007 Other Vaccine HPV
Prev Doses 1
Site Right arm
Symptom Text: Patient given second dose of HPV vaccine 2 weeks after receiving the first dose. No adverse reaction. No treatment needed. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none None Unknown None


Page 1585
Days 1
Received Date 24-Apr-2007 Lot U2106AA 0187U
State OH
Prev Doses 0 0
NO CONDITIONS, NOT SERIOUS Activities of daily living impaired, Dizziness
Symptom Text: Persistant dizziness for several days, prevented her from working for 1-2 days Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Acne None uncertain~DTaP (unknown mfr)~1~0~In Patient Septra


Page 1586
Days 0
Received Date 25-Apr-2007 Lot NE12410
State FR
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Erythema, Oedema peripheral, Skin warm
Symptom Text: Information has been received from a physician concerning a 13 year old female with no relevant past medical history, and no history of allergies, who on 10APR-2007 was vaccinated intramuscularly into the left upper arm with the first dose of Gardasil (Batch # NE12410). On 10-Apr-2007, a few hours post vaccination, the patient experienced swelling of the entire left arm including the fingers with redness and warmth. The patient was treated with cortisone and antiallergic agents. At the time of this report, the patient had not recovered. The reporting physician felt that the events were important for other medical events. Additional information has been requested. Other business partner numbers include E2007-02275. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown None


Page 1587
Days 0
State MI
Prev Doses 0
Site Unknown
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS Condition aggravated, Facial palsy, Guillain-Barre syndrome, Inappropriate schedule of drug administration
Symptom Text: Information has been received from a registered nurse, concerning a 50 year old female with hearing loss (16-AUG-2007), a facial nerve disorder, Lyme disease with arthritis, pruritus, multiple allergic reactions to antibiotics including tetracycline, CECLOR and KEFLEX, and multiple drug hypersensitivities including morphine, and propoxyphene and DARVOCET, who on 21-FEB-2007 was vaccinated with the first dose, 0.5 ml, IM in the left deltoid, of Gardasil (lot #656372/0243U). Concomitant therapy included INDERAL, MINOCIN, TRILISATE TABLETS/LIQUID), DIAMOX and MIDRIN. On 05-APR-2007 the patient was hospitalized after she developed facial palsy. The nurse reported that on 09-APR-2007, the patient called the office to report her condition. The patient remained hospitalized until 16-APR-2007, and on that day she called the office, and stated that she "had a possible diagnosis of Guillian Barre syndrome." The patient reported she believed that Gardasil caused her condition, and had requested a human papilloma virus antibody test. The reporter considered the event of facial palsy and possible Guillian Barre syndrome to be an other significant medical event. Additional information has been requested. MIDRIN, DIAMOX, TRILISATE TABLETS/LIQUIS, MINOCIN, INDERAL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Hearing loss; Facial nerve disorder; Lyme disease; Pruritus; Arthritis; Allergic reaction to antibiotics; Drug hypersensitivity Unknown


Page 1588
Days 0
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Dizziness, Fatigue, Nausea
Symptom Text: Vaccia given 2:45 - on 2/22/07 - for remainder of day. Patient felt increase fatigue, lightheaded, nauseated. Spent day in nurse office sleeping. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1589
Days 3
State MI
Prev Doses 1
Symptom Text: Hives, was treated with relief with Benedryl and prednisone Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: NOne reported None reported


Page 1590
Vaers Id: 277385-1 (S) Age Gender Vaccine Date F 20-Mar-2007 13.0 VAX Detail: Type MNQ HEPA HPV4 Seriousness: MedDRA PT
Days 17
State CA
Manufacturer AVENTIS PASTEUR SMITHKLINE BEECHAM MERCK & CO. INC.
Lot Prev Doses 42159AA 0 AHAVB129AA 1 00114 0
ER VISIT, HOSPITALIZED, SERIOUS Henoch-Schonlein purpura
Symptom Text: Developed Henoch-Schonlein-Purpura 4/6/07. Received Hepatitis A vaccine, HPV, & MVC-4 vaccine on 3/20/07. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Had mild hematuria which has now resolved none none n/a~~NULL~~In Patient


Page 1591
Days 1
Received Date 25-Apr-2007 Lot AC52B005CA 0955F 1209F 121974AB
State NC
Manufacturer GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 0 0 0 0
Right arm Left arm Right arm
ER VISIT, NOT SERIOUS Eye swelling, Headache, Rash, Throat tightness, Wheezing
Symptom Text: 1 hr after visit eyes swollen, rash on both wrists, wheezing (Hx of Asthma), HA, took 2 ASA for HA and Benadryl. Also tightness in throat. Better with in 15 minutes of Benadryl. Pt was on no allergy meds at this time. Hx of Asthma-been on Flonase, Claritin, Albuterol in past Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Allergy testing by Allergist (+) Skin test to Menactra Asthma


Page 1592
Days 1
State PA
Prev Doses 1
ER VISIT, NOT SERIOUS Dyspnoea, Injection site pruritus, Urticaria
Symptom Text: Pt's school nurse called pt c/o SOB at school. Also c/o itching and Welt at site of 2nd Gardasil injection site. Advised to send pt to closest ER for evaluation. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None Seasonal allergies None


Page 1593
Days 0
State AL
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Diarrhoea, Dry mouth, Dysphagia, Dyspnoea, Headache, Throat tightness
Symptom Text: Information has been received from a physician concerning a 21 year old female who on approximately 10-APR-2007 was vaccinated with a first dose of Gardasil. On approximately 10-APR-2007 the patient experienced dry mouth, tightness in her throat, difficulty swallowing, shortness of breath, diarrhea and headache. The patient was treated with dexamethasone injection and Benadryl injection. Subsequently, the patient recovered. There were no laboratory or diagnostic tests performed. The reporting physician considered dry mouth, tightness in her throat, difficulty swallowing, shortness of breath, diarrhea and headache to be other important medical events. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Unknown


Page 1594
Onset Date Unknown
Days
State NC
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Renal failure
Symptom Text: Information has been received from a physician concerning a 12 year old female patient with a history of "kidney failure" who was vaccinated with a dose of Gardasil. The patient had a complete kidney failure a few days after getting the Gardasil. Unspecified medical attention was sought by the patient. The outcome of the patient was unknown at the time of this report. Upon internal review, kidney failure was considered to be an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Renal failure


Page 1595
Vaers Id: 277413-1 Age Gender U Unknown VAX Detail:
Onset Date Unknown
Days
Received Date 26-Apr-2007 Lot 1250F U2208AA 0014U C26900AA
State MO
Type VARCEL MNQ HPV4 TDAP
Manufacturer MERCK & CO. INC. AVENTIS PASTEUR MERCK & CO. INC. AVENTIS PASTEUR
Prev Doses 1 0 0 5
NO CONDITIONS, NOT SERIOUS Anaphylactic reaction, Dyspnoea, Rash, Wheezing
Symptom Text: Anaphylaxis, rash, wheezing, mild difficulty breathing. Recovered completely with steroids, Benadryl, etc. Has since had second Gardasil, no problems. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None


Page 1596
Onset Date Unknown
Days
State --
Prev Doses 1
Site Right arm
NO CONDITIONS, NOT SERIOUS Blood pressure decreased, Heart rate decreased, Syncope vasovagal
Symptom Text: Increase vagal response after HPV shot, decrease BP, decrease HR, 98/60 ---> 88/56, 74---> 40 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1597
Days 2
State NY
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Arthralgia, Myalgia, Pain
Symptom Text: PATIENT DESCIRBED MUSCLE ACHES AND JOINT PAIN ABOUT 2 DAYS AFTER RECEIVING INITIAL DOSE OF GARDASIL ON 3/8/07. PATIENT CONTINUED WITH BODY ACHES AND JOINT PAIN UP UNTIL APRIL 6TH PATIENT REPORT THIS ON DATE 2ND INJECTION WAS TO BE GIVEN ON 4/20/2007. PATIENT HAD CONTACTED HER PCP WHO ADVISED HER NOT TO CONTINUE THE SERIES. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1598
Onset Date Unknown
Days
Status Date 03-May-2007 Site Left leg
State NH
Mfr Report Id NH0719 Route Intramuscular
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Inappropriate schedule of drug administration, Medication error, Unevaluable event
Symptom Text: Sisters in same exam room; both due to receive HPV vaccine and Menactra. 12 y/o patient received 1 dose of HPV vaccine in each arm, I'm simultaneously, instead of 1 dose HPV and 1 dose Menactra. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none none


Page 1599
Days 0
Received Date 26-Apr-2007 Lot C2690AA 0014U U2208AA
State MO
Prev Doses 5 0 0
Right arm
ER VISIT, NOT SERIOUS Anaphylactic reaction, Dyspnoea, Rash, Wheezing
Symptom Text: Anaphylaxis, rash, wheezing, mild difficulty breathing. Recovered completely with steroids, Benadryl etc. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Concerta 18 mg none none


Page 1600
Days 1
Received Date 26-Apr-2007 Lot C2632AA 0387U
State MO
Prev Doses 0 0
ER VISIT, NOT SERIOUS Dizziness, Fatigue, Hypersensitivity, Nausea, Pruritus, Rash
Symptom Text: Patient developed itching and rash on her chest which is a typical location for her when she has an allergic reaction. Also had dizziness, fatigue and nausea. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Orthotricyclen, Allegra D, Differin gel none Sulfa drugs none


Page 1601
Days 0
State DE
Prev Doses
ER VISIT, NOT SERIOUS Head injury, Loss of consciousness
Symptom Text: Pt passed out after injection - Head injury obtained. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None None None


Page 1602
Days 4
State TX
Prev Doses 2
Site Right arm
NO CONDITIONS, NOT SERIOUS Dizziness, Insomnia, Nausea
Symptom Text: Light-headedness and nausea, mostly with position changes or walking, lasting up to 2 hrs, relieved with lying down, for 3 days, beginning 4 days after receiving 3rd Gardasil vaccine. Had 2 episodes 1st day, then 4 episodes next day. Came in for eval 3rd day, had brief episode that morning, and for 2 min. while standing in office. Menses started 2nd day. Also some difficulty falling asleep 1st and 2nd days. Symptoms all resolved by 4th day, was reportedly back to normal. No treatment given except recommendation to increase fluids, get up slowly. none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Fasting complete metabolic profile and CBC were WNL. none none


Page 1603
Onset Date Unknown
Days
State VA
Prev Doses 0
Symptom Text: Patient received Gardasil vaccine on 4-11-07. On 4-25-07, patient had + pregnancy test. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sinusitis, no fever Xanax, Lexapro, Lamictal, Prilosec, Depo shots Beta HCG = 135, 364 on 4-25-07


Page 1604
Days 0
State --
Prev Doses 0
Site Unknown
ER VISIT, LIFE THREATENING, SERIOUS Convulsion, Gaze palsy, Loss of consciousness, Muscle twitching, Oxygen supplementation, Stomach discomfort, Unresponsive to stimuli
Symptom Text: Information has been received from a licensed practical nurse (LPN) concerning a 13 year old female patient who on 07-MAR-2007 was vaccinated IM in the right deltoid with the first dose, 0.5ml, of Gardasil (Lot #657006/0188U). There was no concomitant medication. The nurse reported that on 07-MAR-2007, 10 minutes after the vaccine was administered, the patient complained of an upset stomach, and then passed out. The nurse reported that the patient's breathing was normal, but she did not regain conscious or respond to verbal stimulation; "the patient's eyes then "rolled back in her head and she began twitching with seizure like activity." The patient's pulse oximetry results were between 80# to 100%, and oxygen was administered. The nurse stated that 911 was called, and an intravenous line was started with Valium, 10 mg, administered prior to the ambulance arrival. The patient was taken to the ER, but was not admitted, and her symptoms "lasted at least 20 minutes." The nurse confirmed that the patient had recovered on the same day, 07-MAR-2007, and added that on 12-APR-2007, when the patient returned to the office, her exam revealed no symptoms. The nurse considered the events to be life threatening, and an other important medical event. Additional information has been requested. None Other Meds: pulse oximetry 03/07/07 80%; pulse oximetry 03/07/07 100% Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1605
Days 0
State SD
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Muscle spasms, Muscular weakness, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Pain in extremity, Pain in extremity
Symptom Text: Pt is in with left arm pain. She said she used to get some cramps or charley horse occasionally somewhere in her hand between the third and fourth digits kind of "like toe cramps". Subsequently she got more cramps the day of the shot and then started developing an allusive pain in the anterior shoulder across the pectoral region and anterior deltoid and then down the arm into the radial forearm and into the hand. The pain migrates a little bit worse with use. It dose not keep her from sleeping at night. She notes that her hand is somewhat weaker and it has been progressively getting worse for the last 2 weeks. She has not had any neck pain. Denies any loss of sensation. No color change. No temperature change or coldness or circulatory symptoms. She received the Gardasil on 0406-07 left deltoid. 2 months ago she was Indian wrestling and somewhat wrenched her neck a little bit and had some minor discomfort and when she extends her head she has a little bit of pain or discomfort at the base of her neck. No history of neck pain. No history of cervical disk problems, any other injury, or trauma to the left upper extremity. No other neurologic symptoms. No fevers. No URI symptoms, respiratory complaints, no cough, wheezy, dyspnea, no cardiac complaints. No abdominal pain, diarrhea or vomiting. No urinary frequency, dysuria or change, No gross weight change or any constitutional symptoms. No swelling of the extremities. No skin rashes or unusual markings. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1606
Days 0
State OH
Prev Doses
Site Right arm
Symptom Text: Pain at injection site Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Asthma-Albuterol Orthocycline low


Page 1607
Vaers Id: 277591-1 Age Gender M 1.0 VAX Detail: Type HPV4 HEPA
Days 9
Status Date 10-May-2007 Site Left leg Right leg
State WV
Mfr Report Id Route Subcutaneously Unknown
Lot Prev Doses 1118F 0 AHAVB093BA 0
NO CONDITIONS, NOT SERIOUS Body temperature increased, Skin lesion, Varicella
Symptom Text: 9 days after vaccination-temp of 102 and multiple chickenpox lesions on face and trunk-multiple lesions Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1608
Days 0
State CA
Prev Doses 0
Site Right arm
ER VISIT, NOT SERIOUS Fatigue, Syncope
Symptom Text: patient fainted in office approx 10 min. after injection. Patient rested a few minutes then went home. About 3:30pm mother reported child was feeling fatigued and was sleeping. Pt had ER visit later. 2-21-07 pt had a followup appt none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: CT negative, blood work 24 hr pending. On 2-21-07 doctor treated with Amoxicillin for sinusitis Hx hypoglycemia


Page 1609
Days 1
State IN
Prev Doses 1
Site Unknown
Symptom Text: Flu like symptoms after 2nd Gardasil injection Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Synthroid, Estra Step None Hypothyroid


Page 1610
Days 1
State WI
Prev Doses 2
ER VISIT, NOT SERIOUS Chills, Dizziness, Headache, Influenza like illness, Injection site pain, Vaccine positive rechallenge
Symptom Text: In addition to mild tenderness at injection site, flu like symptoms; headache, light headed, chills. No SOB. Miler symptoms with prior Gardasil (Both symptomatic treatment and reassurance. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None NKDA None


Page 1611
Days 0
State MO
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Dysphagia, Dysphonia, Dysphonia, Dyspnoea
Symptom Text: Gardasil - 1st inj 2/27/07 10-11 AM -03:00 pm could not breath, swallow - voice deep- hoarse. Did not go to ER - Fri AM took Benadryl, Baby ASA, throat spray. Lasted 2-3 days office today for 2nd inj told reaction after 1st inj. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns:


Page 1612
Days 1
Received Date 01-May-2007 Lot 0689F
State OH
Prev Doses 1
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Arthralgia, Arthralgia, Arthralgia, Joint swelling
Symptom Text: Information has been received from a physician concerning his daughter, a 23 year old female with no drug reactions or allergies with acne who on 31-AUG2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (Lot # 653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified) and doxycycline. On 30-OCT-2006, the patient was vaccinated, intramuscularly with the second 0.5 ml dose of Gardasil. On approximately 31OCT-2006, "two months after the first dose", the patient experienced arthralgia, with progressive pain in her knees, and wrists, and left wrist swelling. On 26FEB-2007, the patient was vaccinated, intramuscularly with the third 0.5 ml dose of Gardasil. The patient sought unspecified medical attention. Laboratory evaluation revealed elevated sedimentation rate (sed rate), elevated C-reactive protein, negative rheumatoid factor, and antinuclear antibodies (ANA) pending. The physician reported that he believed the pain was causing the patient significant disability as she could not participate in former activities. The patient was treated with ADVIL. At the time of the report, the patient had not recovered. The physician considered the patient's arthralgia with progressive pain in her knees and wrists and left wrist swelling to be disabling. Additional information has been requested. Doxycycline, Hormonal contraceptives Other Meds: erythrocyte - elevated, serum C-reactive - elevated, serum ANA - pending, serum rheumatoid factor - negative Lab Data: History: Prex Illness: Prex Vax Illns: Acne


Page 1613
Days 0
Received Date 01-May-2007 Lot 0014U
State NY
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Convulsion, Hypotension, Loss of consciousness
Symptom Text: Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 23-APR-2007 was vaccinated, intramuscularly, with a 0.5 ml first dose Gardasil (lot #653736/0014U). There were no concomitant medication. On 23-APR-2007, while attempting to leave the physician's office, the patient "appeared to have a seizure" and lost consciousness. It was reported that the incident lasted only a few seconds. When the patient regained consciousness it was discovered that her blood pressure was low. On 23-APR-2007, the patient recovered and was able to leave the physician's office with her mother. Upon internal review, "appeared to have a seizure" was considered to be an other important medical event. Additional information has been requested. None Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: None


Page 1614
Onset Date Unknown
Days
Received Date 01-May-2007 Lot NULL
State --
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Abortion, Drug exposure during pregnancy
Symptom Text: Information has been received via the Merck pregnancy registry, from a licensed practical nurse, concerning a 19 year old female patient who was vaccinated with a first and second dose of Gardasil (dates unspecified), and during the vaccination series discovered she was pregnant (date of the LMP and estimated date of delivery were unspecified). The nurse reported that the patient elected to undergo an abortion for personal reasons, and clarified that this decision was "totally unrelated to receiving Gardasil." Upon internal review, elected to undergo an abortion was considered to be an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = unknown) Unknown


Page 1615
Days 0
State IL
Prev Doses 1
Site Unknown
ER VISIT, NOT SERIOUS Facial palsy, Facial palsy, Hypoaesthesia facial
Symptom Text: Information has been received from a consumer concerning her 18 year old female, daughter with chronic sinusitis and herpes simplex (cold sores in her mouth) and a history of ear infections who in February 2007 was vaccinated by injection with the first dose of Gardasil. Concomitant therapy included VALTREX. On 20-APR-2007, the patient was vaccinated by injection with the second dose of Gardasil. Within a few hours, after receiving the second dose of approximately, 20-APR-2007, the patient felt something strange on the right side of her face. Initially, she felt some numbness. Subsequently, the numbness was accompanied by some paralysis on the right side of her face. She went to her physician and she was diagnosed with a mild case of bells palsy. At the time of the report, the patient had not recovered. Upon internal review, it was determined that Bell's palsy was considered on other important medical event. Additional information has been requested. VALTREX Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Ear infection Herpes simplex; chronic sinusitis


Page 1616
Days 0
State IN
Prev Doses 0
Site Unknown
ER VISIT, NOT SERIOUS Abortion spontaneous, Benign hydatidiform mole, Blighted ovum, Drug exposure during pregnancy
Symptom Text: Information has been received via the pregnancy registry, from a consumer concerning her 16 year old daughter, who was pregnant with an estimated date of conception on 05-JAN-2007, and on 09-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. On 29-MAR-2007, the mother reported that her daughter, who was then "12 weeks pregnant," experienced a miscarriage; the mother added that the pregnancy was considered to be a blighted ovum, which she also referred to as a "mole pregnancy." The mother added that in April 2007, her daughter received the second dose of Gardasil. At the time of this report, it was unknown if the patient had recovered from the events. Upon internal review, blighted ovum, "mole pregnancy" and miscarriage were determined to be an other important medical event. Additional information has been requested. None Other Meds: Unknown Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = 1/5/2007)


Page 1617
Vaers Id: 277669-1 (S) Age Gender Vaccine Date F 18-Apr-2007 17.0 VAX Detail: Type HPV4
Days 0
State CA
Prev Doses 0
ER VISIT, PERMANENT DISABILITY, SERIOUS Dizziness, Fatigue, Feeling hot, Pallor, Paraesthesia, Sensation of heaviness, Syncope, Thirst
Symptom Text: Information has been received from a physician concerning a 17 year old female patient with past episodes of fainting with vaccinations who on 18-APR-2007 was vaccinated IM in the left arm with her first dose of Gardasil, lot #657617/0384U. After receiving the injection the patient fainted, which lasted a few seconds. The patient was completely white in the face and she complained that entire body felt like she was burning up. She was not warm to touch and did not have a fever. The patient kept asking for water. She regained color to her face 15 minutes later. She felt tingling for one hour or so both legs and arms and was very dizzy. Her eyes were closed for approximately 1 hour and she felt exhausted. The patient was given smelling salts and when asked if she was aware of what was being done to her, she "smelled violets". She had a fan on her for 30 minutes and she started to feel better. Her blood pressure was taken 2 or 3 times for approximately one hour and her pulse was also monitored. "Blood pressure reading (90/60 normal for patient). Pulse (60 normal for patient) for first 15 to 30 minutes after reaction was very faint." She was very alert one hour later (eyes open and talking) but complained of her legs feeling heavy. The patient had to be wheeled out to her car. The physician did not believe the patient hyperventilated to bring these reactions on herself. The physician believed giving the patient smelling salts, monitoring the blood pressure, pulse and putting the patient in front of a fan to cool her down was another medical event and the patient's experience was disabling because she went to bed and not able to do anything for rest of the day. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood pressure 04/19/06 90/60, total heartbeat count 04/19/06 60 Syncope; Immunisation


Page 1618
Onset Date 01-May-2007
Days 1
State MO
Prev Doses 0
ER VISIT, NOT SERIOUS Erythema, Swelling face
Symptom Text: 5/1/07 3:30 pm PC from client. States she woke up at noon today with a swollen, red face and "red spots all over both legs. Had received HPV immun on 4/30/07 in the afternoon went to express care at 1:00 pm and was seen by Dr states she was given Benadryl pills and steroid cream. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown None None


Page 1619
Days 20
State CA
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Arthralgia, Arthralgia, Arthralgia, Fatigue, Influenza like illness
Symptom Text: arthralgias of hands and wrists, flu-like symptoms, fatigue, knee and ankle pain starting 2-3 weeks after gardisil vaccine Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1620
Days 1
State MA
Prev Doses 0
Symptom Text: persistent vomiting for several hours resulting in emergency room visit. Treated with Zofran, Ativan and IV fluids. CT Scan needed to rule out intestinal obstruction as patient has Crohn's colitis. Pentasa, Prilosec, Seasonal, Calcium+D supplement Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Blood work for electrolytes - pre and post treatment.CT scan to rule out intestinal obstruction - patient has Crohn's colitis Crohn's colitis None none~~NULL~~In Patient|none~~NULL~~In Sibling1


Page 1621
Days 5
Received Date 02-May-2007 Lot UNKNOWN
State MA
Prev Doses 0
Site Right arm
NO CONDITIONS, NOT SERIOUS Chest pain, Injection site pain
Symptom Text: Chest pain for 4 days which started 5 days after gardasil administration. Also has injection site pain. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none Negative chest Xray and normal EKG. none none


Page 1622
Days 3
State NJ
Mfr Report Id NJ200705 Route Unknown
Prev Doses 1
Site Unknown
ER VISIT, HOSPITALIZED, SERIOUS Grand mal convulsion, Joint contracture, Partial seizures
Symptom Text: 16 year old s/p receiving HPV #2 on 4/6/07. Presented 4/9/07 with possible focal seizure (contracture right hand) sent to ER then admitted with Grand Mal seizure episode that evening. Patient placed on Dilantin discharged home on Dilantin PO. No FMH of seizure episodes. Not Known Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: C-scan of brain (neg), MRI of Brain Negative None None


Page 1623
Days 0
Received Date 03-May-2007 Lot NE43130
State FR
Mfr Report Id WAES0704CZE00002 Route Intramuscular
Prev Doses
Site Unknown
HOSPITALIZED, SERIOUS Back pain, Cardiac murmur, Chest pain, Cough, Dyspnoea, Dyspnoea, Hyperhidrosis, Nausea, Vertigo, Viral infection
Symptom Text: Information has been received from a physician concerning a 16 year old virgin female who on 05-FEB-2007 was vaccinated (first dose) with Gardasil. There was no concomitant medication, no medical history information. On 05-FEB-2007 the patient experienced vertigo, back pain, chest pain, difficulties in breathing, cough, nausea and sweating and was hospitalized. Subsequently, the patient recovered and was on 08-FEB-2007 discharged from the hospital. The final diagnosis made by hospital physicians was virosis. According to the hospital chart these adverse experiences were not taken as related to vaccination. Based on the re-evaluation of the situation by the physician, administering vaccine, vertigo, back pain, chest pain, difficulties in breathing and cough, nausea and sweating could be possibly related to therapy with Gardasil. Administering physician received the information about patient's hospitalization on 11-APR2007 when patient was visiting the site in order to obtain second dose of Gardasil vaccine. Vaccination was not performed, physician requested detailed information about hospitalization. - Based on the hospital chart, patient was vaccinated around 3p.m. on 05-FEB-2007. Although patient was informed that she should eliminate any physical activity for 48 hours after vaccination patient went to her temporary job at 6p.m. Patient reported that there was close weather and she experienced vertigo. On 7p.m. patient went to a dancing class and smoked a cigarette, nevertheless she didn't practice because of back pain, vertigo and cough. At 8p.m. patient went together with her friends to a restaurant, smoked cigarettes and experienced nausea, vertigo and sweating. On the way home patient climbed the stairs (4, floor) and experienced difficulty in breathing. Consequently, ambulance was called and patient was admitted to hospital. Cardiological examination excluded cardiac reason of chest pain (accidental murmur present). Total bilirubin was slightly increased (25.8), BP 115/60, temperature 37.7 deg C. Additiona None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: blood pressure 05Feb07 115/60 mmHg, body temp 05Feb07 37.7 deg C, total serum bilirubin 05Feb07 25.8 micromol/L slightly increased None


Page 1624
Days 1
State AZ
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Symptom Text: Information has been received from a physician concerning a 16 year old female (also reported as 18 year old ) who on 16-APR-2007 was vaccinated with a dose of Gardasil. Since 1 day post-injection, the patient had progressive bilateral leg numbness and weakness and motor weakness. The physician inquired about the possibility of Guillian Barre Syndrome. At the time of this report, the outcome was unknown. Upon internal review, progressive bilateral leg numbness and weakness and motor weakness were considered to be other important medical events. No further information is available. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1625
Vaers Id: 277815-1 (S) Age Gender Vaccine Date F 29-Jan-2007 18.0 VAX Detail: Type MNC HPV4
Days 0
Received Date 03-May-2007 Lot NULL 1447F
State MA
Prev Doses 0
ER VISIT, PERMANENT DISABILITY, SERIOUS Muscular weakness, Paraesthesia, Paraesthesia
Symptom Text: Information has been received from a physician concerning an 18 year old female patient who on 29-JAN-2007 was vaccinated in her left arm with her first dose of Gardasil, lot #655617/1447F. Concomitant therapy included meningococcal vaccine (unspecified). On 29-JAN-2007 after receiving the injection the patient experienced weakness and tingling in her left arm which spread over the entire length of her arm and also to her jaw. She experienced so much discomfort in her jaw that she had difficulty chewing. An examination of the patient ruled out Guillain-Barre Syndrome. The above reaction eventually resolved in two weeks and on approximately 12-FEB-2007, the patient recovered. The physician considered the events to be disabling. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1626
Days 0
State GA
Prev Doses 2
ER VISIT, PERMANENT DISABILITY, SERIOUS Inappropriate schedule of drug administration, Injected limb mobility decreased, Insomnia, Musculoskeletal pain
Symptom Text: Information has been received from a registered nurse concerning a 35 year old female with a history of papilloma viral infection who on unspecified dated, was vaccinated with the first and second dose of Gardasil. 04-APR-2007, the patient was vaccinated with a third dose of Gardasil (lot # 654702/0011U) 0.5 ml IM into the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN, and ALLEGRA-D. On 05-APR-2007, the patient sought medical attention by contacting the physician's office. The patient reported that on 04-APR-2007, immediately after being vaccinated with the third dose of vaccine, she noticed symptoms. She had severe shoulder pain. The patient could not lift her arm laterally and could not sleep due to the pain. The patient was ordered MEDROL DOSE PACK, heat, and LORCET PLUS. The patient had also been seen at an orthopedics office. She was given 2 steroid injections and she is being set up for physical therapy. The patient did not have any symptoms with the first two doses of vaccine. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. The reporter felt that the events were disabling. Additional information has been requested. ORTHO TRI-CYCLEN, ALLEGRA-D Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None Papilloma viral infection


Page 1627
Vaers Id: 277817-1 (S) Age Gender Vaccine Date F Unknown Unknown VAX Detail: Type MNQ HPV4
Onset Date Unknown
Days
Received Date 03-May-2007 Lot NULL NULL
State LA
Prev Doses 0
HOSPITALIZED, SERIOUS Loss of consciousness
Symptom Text: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil, injection. Concomitant therapy included MENACTRA. Subsequently on an unspecified date, the patient "passed out" 15 minutes after receiving Gardasil. The patient was sent to the hospital but the length of stay was unknown. Subsequently on an unspecified date, the patient recovered from the event. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1628
Days 0
Received Date 03-May-2007 Lot 42183AA 00124 1280F
State MD
Prev Doses 0 0 1
Right arm
ER VISIT, NOT SERIOUS Injection site erythema, Injection site irritation, Injection site pruritus
Symptom Text: Pt noted pruritis at the injection site on the afternoon after administration followed by erythema and a burning sensation also localized to the injections site. She was seen 4 days later when the erythema measured 13 x 7.5 cm. There were no other sx, constitutional or otherwise. Flonase, Zaditor Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: None. Trichamonis vaginosa and allergic rhinitis


Page 1629
Days 1
State AZ
Prev Doses 0
Site Unknown
ER VISIT, LIFE THREATENING, PERMANENT DISABILITY, SERIOUS Dyspnoea, Ear pain, Injection site erythema, Injection site swelling, Malaise, Nasal congestion, Pharyngeal oedema, Pharyngolaryngeal pain, Tinnitus
Symptom Text: Information has been received from a health Medical Assistant (N.A.) concerning a 22 year old female patient who is currently sexually active and had a history of thyroid cancer in OCT-2006. On 19-APR-2007 patient was vaccinated IM in left deltoid with a first dose of Gardasil, lot #657617/0384U. Concomitant therapy included LOESTRIN and LEVOXYL. The medical assistant reported that one or two days post injection the patient's injection site was little red, swollen and puffy. On 23-APR-2007 patient called the office saying she had not felt good since getting the injections. The injection site was no longer red or swollen and she had no fever but her throat was swollen and she was having trouble breathing (unknown time period injections site reaction resolved and new symptoms occurred). The patient was complaining of a stuffy nose, sore throat, ears ache and ringing of the ears. She wanted to "pull her hair out" because of the ringing of the ears. The patient was instructed to go to the Emergency room (ER) or walk in clinic for treatment. The outcome of trouble breathing, ear pain, feeling unwell, nasal congestion, throat was swollen, sore throat and ringing of the ears was not recovered. The reporter considered the event "difficulty breathing" to be life threatening. The reporter felt the events to be disabling because the patient was not able to go to work or school. Additional information has been requested. LOESTRIN, LEVOXYL Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Thyroid cancer Sexually active


Page 1630
Days 7
State CT
Prev Doses
Site Unknown
NO CONDITIONS, NOT SERIOUS Uveitis
Symptom Text: Information has been received from a physician concerning a 17 year old female with anxiety who on 09-MAR-2007 was vaccinated intramuscularly with Gardasil (Lot#654389/0961F). Concomitant therapy included Celexa. At the time of vaccination the patient had mild pharyngitis. On 16-MAR-2007 the patient developed bilateral uveitis. The patient was treated with unspecified oral steroids and a periocular kenolg injection. The physician reported that the patient was evaluated for sarcoid which was negative. The patient was also evaluated for arthritis, at the time of this report the results were pending. The uveitis was considered an other medical event. Additional information has been requested. CELEXA Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Anxiety, Pharyngitis Pharyngitis


Page 1631
Onset Date Unknown
Days
State --
Prev Doses
Site Unknown
ER VISIT, NOT SERIOUS Convulsion, Syncope
Symptom Text: Information has been received from a school nurse concerning an approximately 16 year old female who on an unspecified date was vaccinated with a dose of Gardasil. Approximately 5 minutes after receiving the dose, the patient experienced a fainting spell and a seizure. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the patient's seizure was considered an other important medical event. Additional information has been requested. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown Unknown


Page 1632
Vaccine Date 03-May-2007
Onset Date 04-May-2007
Days 1
State NY
Prev Doses 0
NO CONDITIONS, NOT SERIOUS Pruritus generalised
Symptom Text: Pt states she started itching friday on the buttocks and itching has now spread to abdomen and thighs. Pt took Benadryl and was instructed to continue with Benadryl today and call me tomorrow unless it becomes worse and was then told to seek medical attention after discussing this with Dr none Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: none none


Page 1633
Onset Date Unknown
Days
State VA
Mfr Report Id VA07-007 Route Intramuscular
Prev Doses 1
Symptom Text: positive pregnancy test on 4/24/07; HPV4 #2 given 04/02/07 Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: positive urine HCG on 4/24/07 none reported none reported


Page 1634
Days 0
State --
Prev Doses 0
Site Unknown
NO CONDITIONS, NOT SERIOUS Abortion, Drug exposure during pregnancy
Symptom Text: Information has been received from a registered nurse concerning a 17 year old female who was 18 weeks pregnant and was vaccinated with her first dose of Gardasil (lot 653978/0955F) on 29-Nov-2006. There was no concomitant medication. In March 2007, the patient experienced an abortion. The nurse believes that the patient terminated the pregnancy for reasons other than the vaccine. The first dose of the vaccine was given at her pediatrician's office. Subsequently the patient experienced an inappropriate schedule of the vaccine when she received the 2nd dose on 24-Apr-2007. Upon internal review, abortion was considered to be an other important medical event. Additional information has been requested. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Pregnancy NOS (LMP = Unknown) Pregnancy None


Page 1635
Vaers Id: 278266-1 (S) Age Gender Vaccine Date F 28-Mar-2007 Unknown VAX Detail: Type HPV4
Days 5
State --
Mfr Report Id WAES0705MYS00002 Route Unknown
Prev Doses
Site Unknown
PERMANENT DISABILITY, SERIOUS Erythema, Hypersensitivity, Hypoaesthesia, Hypoaesthesia, Pain, Pain in extremity, Pain in extremity, Pruritus generalised, Rash generalised
Symptom Text: Information has been received from a physician concerning a female who on approximately 15-JAN-2007 was vaccinated with Gardasil. On 28-MAR-2007, the patient was vaccinated with a second dose of Gardasil. On 02-APR-2007 the patient experienced itchiness and red spots on whole body. After seven days of itchiness, the patient received an injection to reduce the allergic response on the whole body. On approximately 28-APR-2007 the patient still experienced itchy palms and feet. Additionally the patient experienced aching and numbness in both hands and feet. She complained that it was hard to complete the housework due to aching and numbness. On approximately 01-MAY-2007 the patient experienced red spots and itchiness on face. Subsequently, the patient recovered from itchiness and red spots on whole body. However, the patient's itchy palms and feet as well as aching and numbness persisted. The red spots and itchiness on face also persisted. The reporter felt that itchiness and red spots on whole body, itchy palms and feet, aching, numbness, red spots and itchiness on face were related to therapy with Gardasil. Aching and numbness were considered to be disabling. No further information is available. Unknown Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Unknown


Page 1636
Days 0
State MA
Prev Doses 1
Site Unknown
ER VISIT, PERMANENT DISABILITY, SERIOUS Anorexia, Asthenia, Dizziness, Immediate post-injection reaction, Mobility decreased, Muscular weakness, Nausea, Pain in extremity, Pain in extremity
Symptom Text: Information has been received from a health professional concerning a 26 year old female with sulfonamide allergy who on 22-FEB-2007 was vaccinated, in the left arm, with a first dose of Gardasil (lot # 655849/0263U). There was no concomitant medication. There were no adverse symptoms reported after the first dose. On 24-APR-2007 the patient was vaccinated with Gardasil a second dose. Immediately after the vaccination, the patient experienced left arm pain, nausea, dizziness and loss of appetite. On 25-APR-2007 the patient experienced a lot of pain in her left arm that radiated down to her hand. Her fingers were weak and she was unable to use her hand. Also on that same day the pain radiated to the patient's left leg for a half an hour. Patient was treated with ice and ibuprofen. On 26-APR-2007 the patient recovered. The reporting registered nurse considered unable to use her hand, nausea, loss of appetite, dizziness, fingers were weak, pain in left arm that radiated down her hand, and left leg pain to be disabling. None Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: Sulfonamide allergy None


Page 1637
Vaers Id: 278268-1 (S) Age Gender Vaccine Date F 24-Apr-2007 12.0 VAX Detail: Type MNQ HPV4 HIBV HEPA Seriousness: MedDRA PT
Days 1
Received Date 09-May-2007 Lot NULL NULL NULL NULL
State TX
Mfr Report Id WAES0705USA00797 Route Unknown Unknown Unknown Unknown
Manufacturer SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.
Prev Doses 0
ER VISIT, EXTENDED HOSPITAL STAY, HOSPITALIZED, SERIOUS Groin pain, Headache, Herpes zoster, Meningitis viral, Rash
Symptom Text: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician's office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested. Other Meds: Lab Data: History: Prex Illness: Prex Vax Illns: diagnostic laboratory 04/25/07 - negative Unknown
Total Non Serious Total Serious Non Fatal: Total Death: Total All Reports:
1498 136 3 1637
92% 8% 0%

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Gardasil VAERS Reports

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FDA Freedom of Information Distribution

Report run on: 11 MAY 2007 03:14

VAERS Line List Report

Received Date 14-Jul-2006 Lot 0637F

Status Date 14-Jul-2006

Mfr Report Id Route Unknown

Last Edit Date 13-Nov-2006 Other Vaccine

Site Right arm

FDA Freedom of Information Distribution

VAERS Line List Report

Received Date 16-Mar-2007 Lot NULL

Status Date 21-Mar-2007

Mfr Report Id WAES0702USA03647 Route Unknown

Last Edit Date 22-Mar-2007 Other Vaccine

FDA Freedom of Information Distribution

VAERS Line List Report

Vaccine Date 25-Jul-2006

Onset Date 25-Jul-2006

Received Date 26-Jul-2006 Lot 0637F 0144F

Status Date 28-Jul-2006

Mfr Report Id Route Unknown Unknown

Last Edit Date 10-Aug-2006 Other Vaccine

Manufacturer MERCK & CO. INC. MERCK & CO. INC.

Site Left arm Right arm

NO CONDITIONS, NOT SERIOUS Dyskinesia, Hypertonia, Hypoaesthesia, Hypotonia, Pain, Syncope

FDA Freedom of Information Distribution

VAERS Line List Report

Received Date 01-Aug-2006 Lot 0702F

Status Date 02-Aug-2006

Mfr Report Id Route Unknown

Last Edit Date 02-Aug-2006 Other Vaccine

Site Right arm

NO CONDITIONS, NOT SERIOUS Rash, Swelling

FDA Freedom of Information Distribution

VAERS Line List Report

Received Date 15-Aug-2006 Lot NULL

Status Date 23-Aug-2006

Mfr Report Id WAES0607USA04365 Route Unknown

Last Edit Date 19-Dec-2006 Other Vaccine

ER VISIT, NOT SERIOUS Pain, Swelling

FDA Freedom of Information Distribution

VAERS Line List Report

Vaccine Date 13-Jul-2006

Onset Date Unknown

Received Date 10-Aug-2006 Lot C2457AA 0702F U1920AA

Status Date 11-Aug-2006

Mfr Report Id Route Unknown Unknown Unknown

Last Edit Date 11-Aug-2006 Other Vaccine

Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC. UNKNOWN MANUFACTURER

Site Right arm Left arm Left arm

NO CONDITIONS, NOT SERIOUS Dizziness, Lymphadenopathy, Nausea

FDA Freedom of Information Distribution

VAERS Line List Report

Vaccine Date 12-Jul-2006

Onset Date 12-Jul-2006

Received Date 15-Aug-2006 Lot NULL NULL

Status Date 23-Aug-2006

Mfr Report Id WAES0607USA041063 Route Unknown Unknown

Last Edit Date 25-Apr-2007 Other Vaccine

Manufacturer UNKNOWN MANUFACTURER MERCK & CO. INC.

Site Unknown Unknown

ER VISIT, NOT SERIOUS Rash

FDA Freedom of Information Distribution

VAERS Line List Report